FLUTAMIDE
Flutamide Capsules USP, 125 mg
Approved
Approval ID
328910be-4d0e-4d7b-a062-e3ce0cf793b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2018
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FLUTAMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-915
Application NumberANDA075780
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUTAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2018
FDA Product Classification
INGREDIENTS (15)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FLUTAMIDEActive
Quantity: 125 mg in 1 1
Code: 76W6J0943E
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT