Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

Basic Information

Product Name

FDA Product Code

16714-803

Regulatory Information

NDC Product Code

16714-803

Application Number

ANDA040480

Marketing Category

C73584

Effective Date

January 11, 2024

Territorial Authority

USA

FDA Title

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) (CII)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

AMPHETAMINE ASPARTATE

Quantity: 1.875 mg in 1 1

Code: H527KAP6L5

Class Code: ACTIB

AMPHETAMINE SULFATE

Quantity: 1.875 mg in 1 1

Code: 6DPV8NK46S

Class Code: ACTIB

DEXTROAMPHETAMINE SULFATE

Quantity: 1.875 mg in 1 1

Code: JJ768O327N

Class Code: ACTIB

DEXTROAMPHETAMINE SACCHARATE

Quantity: 1.875 mg in 1 1

Code: G83415V073

Class Code: ACTIB

Active Moieties