Febuxostat
FEBUXOSTAT TABLETS. These highlights do not include all the information needed to use FEBUXOSTAT TABLETS safely and effectively. See full prescribing information for FEBUXOSTAT TABLETS. FEBUXOSTAT tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
97a8c7fc-0a66-2ddc-e053-2a95a90ad313
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code51407-293
Application NumberANDA205414
Product Classification
M
Marketing Category
C73584
G
Generic Name
Febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FEBUXOSTATActive
Quantity: 40 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB
Febuxostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-294
Application NumberANDA205414
Product Classification
M
Marketing Category
C73584
G
Generic Name
Febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FEBUXOSTATActive
Quantity: 80 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB