43063-688 : Morphine Sulfate Extended Release 30 mg Oral Tablet, Film Coated, Extended Release

NDC:	43063-688
Labeler:	Pd-rx Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Morphine Sulfate Extended Release
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA074862
Rev. Date:	Jul 21, 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;30
Shapes:	Round
Colors:	Purple
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:

• 43063-688-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43063‑688‑30)
• 43063-688-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43063‑688‑60)
• 43063-688-90: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43063‑688‑90)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Cetostearyl Alcohol
• Hydroxyethyl Cellulose (140 Cps At 5%)
• Hypromelloses
• Magnesium Stearate
• Polyethylene Glycols
• Polysorbate 80
• Talc
• Titanium Dioxide
• Lactose
• D&c Red No. 7
• Fd&c Blue No. 1

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 43063-684 Morphine Sulfate Extended Release 60 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.
• 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
• 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.
• 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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