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
NDC Product Code50268-339
Application NumberANDA077731
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameFluconazole
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
NDC Product Code50268-337
Application NumberANDA077731
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameFluconazole
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