ULORIC
These HIGHLIGHTS do not include all the information needed to use ULORIC safely and effectively. See full prescribing information for ULORIC. ULORIC (febuxostat) tablet for oral useInitial U.S. Approval: 2009
Approved
Approval ID
ae1e0d8a-03fc-419b-9d44-afa68fbd5681
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-516
Application NumberNDA021856
Product Classification
M
Marketing Category
C73594
G
Generic Name
febuxostat
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (7)
febuxostatActive
Quantity: 80 mg in 1 1
Code: 101V0R1N2E
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT