54868-5388 : Dextroamphetamine Sulfate 15 mg Extended Release Capsule

NDC:	54868-5388
Labeler:	Physicians Total Care, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Dextroamphetamine Sulfate
Dosage Form:	Oral Capsule, Extended Release
Application #:	ANDA076137
Rev. Date:	Aug 15, 2005
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:	barr;956
Shapes:	Capsule
Colors:	Brown
Size (mm):	16
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:

• 54868-5388-0: 10 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5388‑0)
• 54868-5388-1: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5388‑1)

Active Ingredients:

• Dextroamphetamine Sulfate

Inactive Ingredients:

• Silicon Dioxide
• Dibutyl Sebacate
• Ethylcelluloses
• Methylcellulose (15 Cps)
• Povidone
• Propylene Glycol
• Sucrose
• Starch, Corn
• Talc
• Ferrosoferric Oxide
• Gelatin
• Ferric Oxide Red
• Titanium Dioxide
• Ferric Oxide Yellow
• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Blue No. 2
• Fd&c Red No. 40
• Aluminum Oxide
• Shellac

Pharmaceutical Classes:

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]

Related Products:

Based on records with the same trade name.

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