Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
Products1
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
68071-2557Application Number
ANDA077253Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 17, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 150 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT