Fluconazole
Fluconazole Tablets USP
Approved
Approval ID
c94b8ecf-249f-42d6-a030-4cfb83fddb08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9134
Application NumberANDA078423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2021
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FLUCONAZOLEActive
Quantity: 100 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT