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Opana

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Overview

What is Opana?

OPANA ER extended-release tablets are for oral use and contain oxymorphone, an opioid agonist.  OPANA ER extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration.  The tablet strength describes the amount of oxymorphone hydrochloride per tablet.

The tablets contain the following inactive ingredients: hypromellose, polyethylene oxide, polyethylene glycol, α-tocopherol, citric acid, polyvinyl alcohol, titanium dioxide, macrogol and talc.

In addition, the 5 mg, 7.5 mg and 30 mg tablets contain iron oxide red. The 7.5 mg tablets contain iron oxide black, and iron oxide yellow. The 10 mg tablets contain FD&C yellow No. 6. The 20 mg tablets contain FD&C blue No. 1, FD&C yellow No. 6, and D&C yellow No. 10. The 40 mg tablets contain FD&C yellow No. 6, and D&C yellow No. 10.

The structural formula for oxymorphone hydrochloride is as follows: 



What does Opana look like?



What are the available doses of Opana?

Extended-release tablets: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

What should I talk to my health care provider before I take Opana?

How should I use Opana?

OPANA ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

OPANA ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

OPANA ER is administered orally every 12 hours.


What interacts with Opana?

Sorry No Records found


What are the warnings of Opana?

Sorry No Records found


What are the precautions of Opana?

Sorry No Records found


What are the side effects of Opana?

Sorry No records found


What should I look out for while using Opana?

OPANA ER is contraindicated in patients with:

OPANA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.  Assess each patient’s risk prior to prescribing OPANA ER, and monitor all patients regularly for the development of these behaviors and conditions [ ].

Serious, life-threatening, or fatal respiratory depression may occur with use of OPANA ER.  Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole; crushing, chewing, or dissolving OPANA ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone [ ].

Accidental ingestion of even one dose of OPANA ER, especially by children, can result in a fatal overdose of oxymorphone [ ].

Prolonged use of OPANA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [ ].

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking OPANA ER. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone [ ].

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [ ].


What might happen if I take too much Opana?

Clinical Presentation

Acute overdosage with OPANA ER can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations .

Treatment of Overdose

In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose.

For clinically significant respiratory or circulatory depression secondary to oxymorphone overdose, administer an opioid antagonist.  Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxymorphone overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of oxymorphone in OPANA ER, carefully monitor the patient until spontaneous respiration is reliably reestablished. OPANA ER will continue to release oxymorphone and add to the oxymorphone load for 24 hour to 48 hours or longer following ingestion, necessitating prolonged monitoring.  If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed in the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered.  If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.


How should I store and handle Opana?

Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).OPANA ER extended-release tablets are supplied as follows:5 mgPink, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “5” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-812-60Bottles of 100 with child-resistant closure                      NDC 63481-812-70Unit-Dose package of 20 tablets(2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-812-207.5 mgGray, round, film coated, biconcave extended-release tablets debossed with an “E” on one side and a “7 ½” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-813-60Bottles of 100 with child-resistant closure                      NDC 63481-813-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-813-2010 mgLight orange, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “10” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-814-60Bottles of 100 with child-resistant closure                      NDC 63481-814-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-814-2015 mgWhite, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “15” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-815-60Bottles of 100 with child-resistant closure                      NDC 63481-815-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-815-2020 mgLight green, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “20” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-816-60Bottles of 100 with child-resistant closure                      NDC 63481-816-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-816-2030 mgRed, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “30” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-817-60Bottles of 100 with child-resistant closure                      NDC 63481-817-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-817-2040 mgLight yellow to pale yellow, round, film-coated, biconcave extended-release tablets debossed with an “E” on one side and a “40” on the other side.Bottles of 60 with child-resistant closure                        NDC 63481-818-60Bottles of 100 with child-resistant closure                      NDC 63481-818-70Unit-Dose package of 20 tablets (2 blister cards of 10 tablets, not child-resistant, for hospital use only)                                                      NDC 63481-818-20Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxymorphone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of analgesia, the principal therapeutic action of oxymorphone, is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Non-Clinical Toxicology
OPANA ER is contraindicated in patients with:

OPANA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.  Assess each patient’s risk prior to prescribing OPANA ER, and monitor all patients regularly for the development of these behaviors and conditions [ ].

Serious, life-threatening, or fatal respiratory depression may occur with use of OPANA ER.  Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole; crushing, chewing, or dissolving OPANA ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone [ ].

Accidental ingestion of even one dose of OPANA ER, especially by children, can result in a fatal overdose of oxymorphone [ ].

Prolonged use of OPANA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [ ].

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking OPANA ER. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone [ ].

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [ ].

Potassium-sparing diuretic, angiotensin converting enzyme inhibitors (see ).

OPANA ER contains oxymorphone, a Schedule II controlled substance.  As an opioid, OPANA ER exposes users to the risks of addiction, abuse, and misuseBecause extended-release products such as OPANA ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxymorphone present .

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OPANA ER.  Addiction can occur at recommended doses and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing OPANA ER, and monitor all patients receiving OPANA ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).  The potential for these risks should not, however, prevent the proper management of pain in any given patient.  Patients at increased risk may be prescribed opioids such as OPANA ER, but use in such patients necessitates intensive counseling about the risks and proper use of OPANA ER along with intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of OPANA ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxymorphone and can result in overdose and death.

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.  Consider these risks when prescribing or dispensing OPANA ER.  Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug .  Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 

The following serious adverse reactions are described, or described in greater detail, in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).