Fluconazole
FLUCONAZOLE TABLETS
Approved
Approval ID
892aa268-0790-4e2c-8faa-d8cbeb200abd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2011
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-481
Application NumberANDA076077
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2007
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT