63481-907 : 12 Hr Opana 5 mg Extended Release Tablet


NDC: 63481-907
Labeler: Endo Pharmaceuticals
Product Type: Human Prescription Drug
Drug Name:  Opana ER
Dosage Form: Oral Tablet, Extended Release
Application #: NDA021610
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: 5
Shapes:  Octagon (8 sides)
Colors:  Pink
Size (mm): 8
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:

  • 63481-907-70: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (63481‑907‑70)
  • 63481-907-75: 5 BLISTER PACK IN 1 BOX, UNIT‑DOSE (63481‑907‑75) > 20 TABLET, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

  • Oxymorphone Hydrochloride

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Hypromelloses
  • Methylparaben
  • Sodium Stearyl Fumarate
  • Titanium Dioxide
  • Triacetin
  • Polyethylene Glycols
  • Polysorbate 80
  • Ferric Oxide Red

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
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  • 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.
  • 63481-438 12 Hr Opana 20 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.
  • 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.