FDA Product

Fluconazole

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

Basic Information

Product Name

Fluconazole

FDA Product Code

63629-8970

Regulatory Information

NDC Product Code

63629-8970

Application Number

ANDA078423

Marketing Category

C73584

Effective Date

March 25, 2021

Territorial Authority

USA

FDA Title

Fluconazole Tablets USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

102

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

Quantity: 50 mg in 1 1

Code: 8VZV102JFY

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

Active Moieties

FLUCONAZOLE

Code: 8VZV102JFY

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