NDC product

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

NDC 0527-0791 · Lannett Company, Inc.

Key facts

Product NDC 0527-0791
Proprietary name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Nonproprietary name Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Substances DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Lannett Company, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA214403
DEA schedule CII
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
Marketing start Nov 26, 2021
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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