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

Product NDC

0555-0787

11-digit product format

005550787

Labeler code

0555

Product ID

0555-0787_2ead3340-41f0-43ab-9eb5-53825534fb19

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

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

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Barr Laboratories Inc.

Application

NDA021303

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2009-04-02

Marketing end

2020-07-31

Substance

DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE

Active strength

3 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record