70710-1184 : Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Oral Capsule, Extended Release

NDC:	70710-1184
Labeler:	Zydus Pharmaceuticals (Usa) Inc.
Product Type:	Human Prescription Drug
Drug Name:	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage Form:	Oral Capsule, Extended Release
Application #:	ANDA210080
Rev. Date:	Dec 30, 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:	1184;N
Shapes:	Capsule
Colors:	Orange / Blue
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:

70710-1184-1: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (70710‑1184‑1)

Active Ingredients:

Dextroamphetamine Saccharate
Amphetamine Aspartate Monohydrate
Dextroamphetamine Sulfate
Amphetamine Sulfate

Dosage Strength:

1.25 mg
1.25 mg
1.25 mg
1.25 mg

Inactive Ingredients:

Caprylic/Capric Mono/Di-glycerides
Hydroxypropyl Cellulose (1600000 Wamw)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
Starch, Corn
Sucrose
Talc
Titanium Dioxide
Triethyl Citrate /

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.