0904-6560 : Morphine Sulfate Extended Release 100 mg Oral Tablet, Film Coated, Extended Release

NDC:	0904-6560
Labeler:	Major Pharmaceuticals
Product Type:	Human Prescription Drug
Drug Name:	Morphine Sulfate Extended Release
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA074769
Rev. Date:	Jan 14, 2011
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:	ABG;100
Shapes:	Round
Colors:	Gray
Size (mm):	7
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 0904-6560-61: 100 BLISTER PACK IN 1 CARTON (0904‑6560‑61) > 1 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Cetostearyl Alcohol
• Hydroxyethyl Cellulose (140 Mpa.s At 5%)
• Hypromelloses
• Magnesium Stearate
• Polyethylene Glycols
• Talc
• Titanium Dioxide
• Ferrosoferric Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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• 0904-6558 Morphine Sulfate Extended Release 30 mg Oral Tablet, Film Coated, Extended Release by Major Pharmaceuticals
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• 57664-190 Morphine Sulfate Extended-release Extended-release 30 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
• 57664-191 Morphine Sulfate Extended-release Extended-release 60 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
• 57664-192 Morphine Sulfate Extended-release Extended-release 100 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
• 57664-196 Morphine Sulfate Extended-release Extended-release 15 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
• 57664-197 Morphine Sulfate Extended-release Extended-release 200 mg Oral Tablet by Sun Pharmaceutical Industries, Inc.
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• 72162-1352 Morphine Sulfate Extended Release 200 mg Oral Tablet, Film Coated, Extended Release by Bryant Ranch Prepack

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