Fluconazole
Fluconazole Tablets, USP
Approved
Approval ID
b1ce2a0d-75f1-a760-e053-2a95a90adf8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 4
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 Code51407-301
Application NumberANDA078423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
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
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-302
Application NumberANDA078423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FLUCONAZOLEActive
Quantity: 200 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-299
Application NumberANDA078423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FLUCONAZOLEActive
Quantity: 50 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-300
Application NumberANDA078423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FLUCONAZOLEActive
Quantity: 100 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT