Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate

Basic Information

Product Name

FDA Product Code

55466-129

Regulatory Information

NDC Product Code

55466-129

Application Number

ANDA210754

Marketing Category

C73584

Effective Date

September 26, 2023

Territorial Authority

USA

FDA Title

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DEXTROAMPHETAMINE SULFATE

Quantity: 5 mg in 1 1

Code: JJ768O327N

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Quantity: 5 mg in 1 1

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

AMPHETAMINE ASPARTATE

Quantity: 5 mg in 1 1

Code: H527KAP6L5

Class Code: ACTIB

MALTODEXTRIN

Code: 7CVR7L4A2D

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

AMPHETAMINE SULFATE

Quantity: 5 mg in 1 1

Code: 6DPV8NK46S

Class Code: ACTIB

DEXTROAMPHETAMINE SACCHARATE

Quantity: 5 mg in 1 1

Code: G83415V073

Class Code: ACTIB

Active Moieties