febuxostat

FDA Drug Profile — FEBUXOSTAT, Febuxostat, ULORIC, febuxostat

febuxostat is listed in the FDA National Drug Code directory with 22 NDC codes, marketed under brand names including FEBUXOSTAT, Febuxostat, ULORIC. Available dosage forms: tablet, tablet, coated, powder.

Drug Details

Generic Name
febuxostat
Brand Names
FEBUXOSTAT, Febuxostat, ULORIC, febuxostat
Application Number
ANDA206266
Sponsor
Solco Healthcare US LLC
NDC Codes
22
Dosage Forms
TABLET, TABLET, COATED, POWDER
Routes
ORAL
Active Ingredients
FEBUXOSTAT

Indications and Usage

1 INDICATIONS AND USAGE Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 ) Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.