0228-3227 : Oxymorphone Hydrochloride 5 mg 12 Hr Extended Release Tablet

NDC:	0228-3227
Labeler:	Actavis Elizabeth LLC
Product Type:	Human Prescription Drug
Drug Name:	Oxymorphone Hydrochloride
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA079046
Rev. Date:	Dec 31, 2010
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:	227
Shapes:	Round
Colors:	Pink
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:

• 0228-3227-06: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (0228‑3227‑06)
• 0228-3227-11: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (0228‑3227‑11)
• 0228-3227-50: 500 TABLET, EXTENDED RELEASE IN 1 BOTTLE (0228‑3227‑50)

Active Ingredients:

• Oxymorphone Hydrochloride

Inactive Ingredients:

• Silicon Dioxide
• Hypromelloses
• Magnesium Stearate
• Cellulose, Microcrystalline
• Titanium Dioxide
• Ferric Oxide Red

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 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
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• 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
• 0115-1231 Oxymorphone Hydrochloride 5 mg 12 Hr Extended Release Tablet by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
• 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.
• 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.
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