febuxostat
Febuxostat Tablets
Approved
Approval ID
0629ab39-196e-4198-902a-3c16277ba205
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
febuxostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1553
Application NumberANDA205443
Product Classification
M
Marketing Category
C73584
G
Generic Name
febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FEBUXOSTATActive
Quantity: 80 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
febuxostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1552
Application NumberANDA205443
Product Classification
M
Marketing Category
C73584
G
Generic Name
febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (11)
FEBUXOSTATActive
Quantity: 40 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT