Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC

72162-2052

11-digit product format

721622052

Labeler code

72162

Product ID

72162-2052_09755346-4e4d-4fd1-a534-73400afd605e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Dosage form

TABLET

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA211352

Marketing category

ANDA

Marketing start

2022-12-29

Substance

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

Active strength

3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes