68084-406 : Morphine Sulfate 100 mg Oral Tablet, Extended Release

NDC:	68084-406
Labeler:	American Health Packaging
Product Type:	Human Prescription Drug
Drug Name:	Morphine Sulfate
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA075295
Rev. Date:	Sep 2, 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:	E658;100
Shapes:	Capsule
Colors:	Blue
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:

• 68084-406-01: 100 BLISTER PACK IN 1 BOX, UNIT‑DOSE (68084‑406‑01) > 1 TABLET, EXTENDED RELEASE IN 1 BLISTER PACK (68084‑406‑11)

Active Ingredients:

• Morphine Sulfate

Inactive Ingredients:

• Silicon Dioxide
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• Stearic Acid
• Fd&c Blue No. 1

Pharmaceutical Classes:

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

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