FEBUXOSTAT
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
73b07a94-c044-42dc-abe4-7d7c860c9638
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
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 Code0527-2244
Application NumberANDA213069
Product Classification
M
Marketing Category
C73584
G
Generic Name
febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (11)
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FEBUXOSTATActive
Quantity: 40 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
febuxostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2248
Application NumberANDA213069
Product Classification
M
Marketing Category
C73584
G
Generic Name
febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FEBUXOSTATActive
Quantity: 80 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT