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
NDC Product Code16590-283
Application NumberANDA076077
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 5, 2012
Generic NameFLUCONAZOLE
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