63481-438 : 12 Hr Opana 20 mg Extended Release Tablet


NDC: 63481-438
Labeler: Endo Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Opana ER
Dosage Form: Oral Tablet, Extended Release
Application #: NDA201655
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: E;20
Shapes:  Round
Colors:  Green
Size (mm): 9
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 63481-438-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63481‑438‑60)
  • 63481-438-70: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (63481‑438‑70)

Active Ingredients:

  • Oxymorphone Hydrochloride

Dosage Strength:

  • 20 mg

Inactive Ingredients:

  • Hypromelloses
  • .alpha.-tocopherol
  • Citric Acid Monohydrate
  • Polyvinyl Alcohol
  • Titanium Dioxide
  • Polyethylene Glycols
  • Talc
  • Fd&c Blue No. 1
  • Fd&c Yellow No. 6
  • D&c Yellow No. 10

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 63481-434 12 Hr Opana 5 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-435 12 Hr Opana 7.5 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-436 12 Hr Opana 10 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-437 12 Hr Opana 15 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-439 12 Hr Opana 30 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-440 12 Hr Opana 40 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-624 Opana 1 mg/ml Intramuscular; Intravenous; Subcutaneous Injection by Endo Pharmaceuticals Inc.
  • 63481-812 12 Hr Opana 5 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-813 12 Hr Opana 7.5 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-814 12 Hr Opana 10 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-815 12 Hr Opana 15 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-816 12 Hr Opana 20 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-817 12 Hr Opana 30 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-818 12 Hr Opana 40 mg Extended Release Tablet by Endo Pharmaceuticals Inc.
  • 63481-522 12 Hr Opana 7.5 mg Extended Release Tablet by Endo Pharmaceuticals
  • 63481-553 12 Hr Opana 15 mg Extended Release Tablet by Endo Pharmaceuticals
  • 63481-571 12 Hr Opana 30 mg Extended Release Tablet by Endo Pharmaceuticals
  • 63481-612 Opana 5 mg Oral Tablet by Endo Pharmaceuticals
  • 63481-613 Opana 10 mg Oral Tablet by Endo Pharmaceuticals
  • 63481-617 12 Hr Opana 20 mg Extended Release Tablet by Endo Pharmaceuticals
  • More related products ...

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.