57664-197 : Morphine Sulfate Extended-release Extended-release 200 mg Oral Tablet

NDC:	57664-197
Labeler:	Sun Pharmaceutical Industries, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Morphine Sulfate Extended-release
Dosage Form:	Oral Tablet
Application #:	ANDA205634
Rev. Date:	Sep 13, 2016
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:	S;200;197
Shapes:	Capsule
Colors:	Green
Size (mm):	14
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:

• 57664-197-88: 100 TABLET IN 1 BOTTLE, PLASTIC (57664‑197‑88)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Lactose Monohydrate
• Hypromelloses
• Hydroxyethyl Cellulose (2000 Mpa.s At 1%)
• Magnesium Stearate
• Stearic Acid
• Butylated Hydroxyanisole
• Butylated Hydroxytoluene
• Polyethylene Glycol 400
• Titanium Dioxide
• Polysorbate 80
• D&c Yellow No. 10
• Aluminum Oxide
• Fd&c Blue No. 1

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 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.
• 0904-6557 Morphine Sulfate Extended Release 15 mg Oral Tablet, Film Coated, Extended Release by Major Pharmaceuticals
• 0904-6558 Morphine Sulfate Extended Release 30 mg Oral Tablet, Film Coated, Extended Release by Major Pharmaceuticals
• 0904-6559 Morphine Sulfate Extended Release 60 mg Oral Tablet, Film Coated, Extended Release by Major Pharmaceuticals
• 0904-6560 Morphine Sulfate Extended Release 100 mg Oral Tablet, Film Coated, Extended Release by Major Pharmaceuticals
• 43063-684 Morphine Sulfate Extended Release 60 mg Oral Tablet, Film Coated, Extended Release by Pd-rx Pharmaceuticals, Inc.
• 43063-688 Morphine Sulfate Extended Release 30 mg Oral Tablet, Film Coated, Extended Release by Pd-rx Pharmaceuticals, Inc.
• 43063-689 Morphine Sulfate Extended Release 15 mg Oral Tablet, Film Coated, Extended Release by Pd-rx Pharmaceuticals, Inc.
• 63629-3979 Ms 30 mg Extended Release Tablet by Bryant Ranch Prepack
• 63629-8505 Morphine Sulfate Extended Release 200 mg Oral Tablet, Film Coated, Extended Release by Bryant Ranch Prepack
• 69189-8040 Morphine Sulfate Extended Release 100 mg Oral Tablet, Film Coated, Extended Release by Avera Mckennan Hospital
• 72162-1352 Morphine Sulfate Extended Release 200 mg Oral Tablet, Film Coated, Extended Release by Bryant Ranch Prepack

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