FDA label
What is budesonide used for?
The FDA-approved uses of budesonide, 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 budesonide (suspension) lists this use: Maintenance Treatment of Asthma.
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Budesonide, suspension
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA211922). Cross-references to other label sections are left out.
Maintenance Treatment of Asthma
Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Limitations of Use:
- Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Source: DailyMed label, set id a39fbcfc-3ffd-44bd-b882-01f8e1844213, version 4, effective April 14, 2026. NDC 47335-631, one of 23 listings for this product.
Budesonide, capsule, coated pellets
Indications and Usage, quoted from the label by Zydus Pharmaceuticals USA Inc. (ANDA206134). Cross-references to other label sections are left out.
Treatment of Mild to Moderate Active Crohn’s Disease
Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older.
Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease
Budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults.
Source: DailyMed label, set id 29863154-5f98-410e-9bf3-0f08b551edef, version 10, effective February 12, 2025. NDC 68382-720, one of 6 listings for this product.
Questions
What is budesonide used for?
The FDA label for budesonide (suspension) lists this use: Maintenance Treatment of Asthma.
What drug class is budesonide?
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.
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- NDC 0186-1988Budesonide NDC record
- NDC 0186-1989Budesonide NDC record
- NDC 0186-1990Budesonide NDC record