Fluconazole

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 829572556

Effective Date

May 1, 2025

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fluconazole(150 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70518-4336

Application Number

ANDA077731

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 1, 2025

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: 8VZV102JFYClass: ACTIBQuantity: 150 mg in 1 1