Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ANI Pharmaceuticals, Inc.
Golden State Medical Supply, Inc.
831049809
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluconazole
Product Details
NDC Product Code
51407-301Application Number
ANDA078423Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2023ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 150 mg in 1 1
Fluconazole
Product Details
NDC Product Code
51407-302Application Number
ANDA078423Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 200 mg in 1 1
Fluconazole
Product Details
NDC Product Code
51407-299Application Number
ANDA078423Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2023ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 50 mg in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
Fluconazole
Product Details
NDC Product Code
51407-300Application Number
ANDA078423Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2023ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 100 mg in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT