Fluconazole
Fluconazole Tablets USP Rx only
Approved
Approval ID
551a5c8f-57eb-2643-12c6-7c700584b49f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 2
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 Code50268-339
Application NumberANDA077731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FLUCONAZOLEActive
Quantity: 200 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-337
Application NumberANDA077731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FLUCONAZOLEActive
Quantity: 100 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB