FDA Product

Tamoxifen Citrate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Tamoxifen Citrate

FDA Product Code

72162-2225

Regulatory Information

NDC Product Code

72162-2225

Application Number

ANDA070929

Marketing Category

C73584

Effective Date

January 26, 2024

Territorial Authority

USA

FDA Title

Tamoxifen Citrate Tablets, USP Rx O nly

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

100

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TAMOXIFEN CITRATE

Quantity: 10 mg in 1 1

Code: 7FRV7310N6

Class Code: ACTIM

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

TAMOXIFEN

Code: 094ZI81Y45

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