52054-514 : Dexedrine 15 mg Extended Release Capsule

NDC:	52054-514
Labeler:	Amedra Pharmaceuticals LLC
Product Type:	Human Prescription Drug
Drug Name:	Dexedrine Spansule
Dosage Form:	Oral Capsule, Extended Release
Application #:	NDA017078
Rev. Date:	Aug 2, 1976
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:	15mg;514;15mg;ap
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.

NDC Package Codes:

52054-514-09: 1 BOTTLE IN 1 CARTON (52054‑514‑09) > 90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE

Active Ingredients:

Dextroamphetamine Sulfate

Dosage Strength:

15 mg

Inactive Ingredients:

Cetyl Alcohol
D&c Yellow No. 10
Dibutyl Sebacate
Ethylcelluloses
Fd&c Blue No. 1
Fd&c Red No. 40
Fd&c Yellow No. 6
Gelatin
Hypromelloses
Polyethylene Glycols
Povidone
Sodium Lauryl Sulfate

Pharmaceutical Classes:

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

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.