FDA label
What is zafirlukast used for?
The FDA-approved uses of zafirlukast, 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: “Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.”
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Zafirlukast, tablet, film coated
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA213163). Cross-references to other label sections are left out.
Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
Source: DailyMed label, set id 8bdb47c5-9d19-4d59-94c8-62c117525e7f, version 1, effective December 1, 2023. NDC 59651-291, one of 8 listings for this product.
Questions
What is zafirlukast used for?
The FDA label says: “Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.”
What drug class is zafirlukast?
FDA lists zafirlukast in the Leukotriene Receptor Antagonist 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.