FDA label
What is zileuton used for?
The FDA-approved uses of zileuton, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.”
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Zileuton, tablet, film coated, extended release
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA215742). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 94313e24-9534-4b6c-b374-c436c4916303, version 2, effective October 14, 2022. NDC 31722-044, one of 2 listings for this product.
Zileuton, tablet, extended release
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA204929). Cross-references to other label sections are left out.
Zileuton Extended-Release Tablets is 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
Source: DailyMed label, set id fd382540-b390-4e86-a94a-988ea89c93a8, version 7, effective May 15, 2024. NDC 64980-206, one of 1 listing for this product.
Questions
What is zileuton used for?
The FDA label says: “Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.”
What drug class is zileuton?
FDA lists zileuton in the 5-Lipoxygenase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.