FDA label
What is Pulmicort Flexhaler used for?
Pulmicort Flexhaler contains budesonide. The FDA-approved uses below are 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 for Pulmicort Flexhaler lists this use: Treatment of Asthma.
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Pulmicort Flexhaler, aerosol, powder
Indications and Usage, quoted from the label by A-S Medication Solutions (NDA021949). Cross-references to other label sections are left out.
Treatment of Asthma
PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.
Limitations of Use:
•PULMICORT FLEXHALER is NOT indicated for the relief of acute bronchospasm.
Source: DailyMed label, set id 10ea5d87-6ed0-4fa5-a37b-2043c8560bc0, version 2, effective November 7, 2023. NDC 50090-6796, one of 1 listing for this product.
Questions
What is Pulmicort Flexhaler used for?
The FDA label for Pulmicort Flexhaler lists this use: Treatment of Asthma.
What drug class is Pulmicort Flexhaler?
FDA lists budesonide in the Corticosteroid 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.
More on Pulmicort Flexhaler
- Is Pulmicort Flexhaler a controlled substance?Federal schedule
- Generic for Pulmicort FlexhalerFDA Orange Book
- What is Budesonide used for?FDA label uses
- Is Budesonide a controlled substance?Federal schedule
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- Generic for TarpeyoFDA Orange Book
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- Corticosteroids listFDA drug class
- NDC 50090-6796Pulmicort Flexhaler NDC record