0115-1231 : Oxymorphone Hydrochloride 5 mg 12 Hr Extended Release Tablet


NDC: 0115-1231
Labeler: Global Pharmaceuticals, Division of Impax Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Oxymorphone Hydrochloride
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA079087
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: G71
Shapes:  Round
Colors:  Purple
Size (mm): 5
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:

  • 0115-1231-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0115‑1231‑01)
  • 0115-1231-03: 1000 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0115‑1231‑03)
  • 0115-1231-08: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0115‑1231‑08)
  • 0115-1231-13: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0115‑1231‑13)

Active Ingredients:

  • Oxymorphone Hydrochloride

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Lactose Monohydrate
  • Hypromelloses
  • Xanthan Gum
  • Magnesium Stearate
  • Polyvinyl Alcohol
  • Polyethylene Glycols
  • Talc
  • Titanium Dioxide
  • Fd&c Yellow No. 6
  • Aluminum Oxide
  • Fd&c Blue No. 2
  • D&c Red No. 27

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0115-1232 Oxymorphone Hydrochloride 10 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-1233 Oxymorphone Hydrochloride 20 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-1234 Oxymorphone Hydrochloride 40 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-1315 Oxymorphone Hydrochloride 7.5 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-1316 Oxymorphone Hydrochloride 15 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-1317 Oxymorphone Hydrochloride 30 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0054-0283 Oxymorphone Hydrochloride 5 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0284 Oxymorphone Hydrochloride 10 mg Oral Tablet by Roxane Laboratories, Inc
  • 0093-5861 Oxymorphone Hydrochloride 5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5862 Oxymorphone Hydrochloride 10 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0228-3227 Oxymorphone Hydrochloride 5 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3228 Oxymorphone Hydrochloride 10 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3229 Oxymorphone Hydrochloride 20 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3230 Oxymorphone Hydrochloride 40 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3261 Oxymorphone Hydrochloride 7.5 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3262 Oxymorphone Hydrochloride 15 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3263 Oxymorphone Hydrochloride 30 mg 12 Hr Extended Release Tablet by Actavis Elizabeth LLC
  • 0406-1009 Oxymorphone Hydrochloride 5 mg Oral Tablet by Mallinckrodt, Inc.
  • 0406-1010 Oxymorphone Hydrochloride 10 mg Oral Tablet by Mallinckrodt, Inc.
  • 10702-070 Oxymorphone Hydrochloride 5 mg Oral Tablet by Kvk-tech, Inc.
  • More related products ...

NDC QR Code

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NDC 0115-1231 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.