Fluconazole
Fluconazole Tablets
Approved
Approval ID
bf4c4af8-9178-4119-b3d0-3579bd570a19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2021
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluconazole
PRODUCT DETAILS
NDC Product Code70518-2087
Application NumberANDA077253
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 29, 2021
Generic NameFluconazole
INGREDIENTS (7)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB