Fluconazole
Fluconazole Tablets USP Rx only
Approved
Approval ID
5b95c88c-41c8-42a5-92f9-09611de09a76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2018
Manufacturers
FDA
Central Texas Community Health Centers
DUNS: 079674019
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 Code76413-161
Application NumberANDA077731
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2017
Generic NameFluconazole
INGREDIENTS (7)
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT