FLUCONAZOLE
FLUCONAZOLE TABLETS
Approved
Approval ID
e256abe8-6315-45cd-9fe9-fa7187e5c634
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code16590-283
Application NumberANDA076077
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUCONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 5, 2012
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FLUCONAZOLEActive
Quantity: 200 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB