NDC product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

NDC 0115-1488 · Amneal Pharmaceuticals of New York LLC

Key facts

Product NDC 0115-1488
Proprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Nonproprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Substances DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA076852
DEA schedule CII
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
Marketing start Feb 16, 2016
Listing certified through Dec 31, 2027

At a glance

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Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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