fluconazole
Fluconazole Tablets, USPRx only
Approved
Approval ID
7882901e-8e90-44f4-9963-5f87602cd5e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2018
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
Products 1
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 Code50436-1139
Application NumberANDA208963
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2018
FDA Product Classification
INGREDIENTS (7)
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT