Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Basic Information

Product Name

FDA Product Code

16714-954

Regulatory Information

NDC Product Code

16714-954

Application Number

ANDA202424

Marketing Category

C73584

Effective Date

February 9, 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

AMPHETAMINE SULFATE

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Class Code: ACTIB

DEXTROAMPHETAMINE SULFATE

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Class Code: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATE

Quantity: 7.5 mg in 1 1

Code: O1ZPV620O4

Class Code: ACTIB

DEXTROAMPHETAMINE SACCHARATE

Quantity: 7.5 mg in 1 1

Code: G83415V073

Class Code: ACTIB

Inactive Ingredients

POVIDONE

Code: FZ989GH94E

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

Active Moieties