zileuton
zileuton is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including ZYFLO, Zileuton. Available dosage forms: tablet, tablet, multilayer, extended release.
Drug Details
- Generic Name
- zileuton
- Brand Names
- ZYFLO, Zileuton
- Application Number
- NDA020471
- Sponsor
- Chiesi USA, Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, TABLET, MULTILAYER, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- ZILEUTON
Indications and Usage
1 INDICATIONS AND USAGE Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma. Zileuton extended-release tablets are a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ( 1 ) Do not use zileuton extended-release tablet to treat an acute asthma attack. ( 1 )