0406-8091 : Oxymorphone Hydrochloride 5 mg Oral Tablet, Extended Release

NDC:	0406-8091
Labeler:	Mallinckrodt, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Oxymorphone Hydrochloride Extended-release
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA202946
Rev. Date:	Jun 27, 2014
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:	8091;M
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:

• 0406-8091-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0406‑8091‑01)

Active Ingredients:

• Oxymorphone Hydrochloride

Inactive Ingredients:

• Hypromellose 2208 (100000 Mpa.s)
• Magnesium Stearate
• Polyethylene Glycols
• Polyvinyl Alcohol
• Cellulose, Microcrystalline
• Silicon Dioxide
• Talc
• Titanium Dioxide
• Ferric Oxide Red

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0406-8092 Oxymorphone Hydrochloride 10 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
• 0406-8093 Oxymorphone Hydrochloride 20 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
• 0406-8094 Oxymorphone Hydrochloride 40 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
• 0406-8095 Oxymorphone Hydrochloride 7.5 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
• 0406-8096 Oxymorphone Hydrochloride 15 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.
• 0406-8097 Oxymorphone Hydrochloride 30 mg Oral Tablet, Extended Release by Mallinckrodt, Inc.

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