FDA label
What is Breyna used for?
Breyna contains budesonide and formoterol. 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 Breyna lists 2 uses: Treatment of Asthma; Maintenance Treatment of Chronic Obstructive Pulmonary Disease.
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Breyna, aerosol, metered
Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA211699). Cross-references to other label sections are left out.
Treatment of Asthma
BREYNA is indicated for the treatment of asthma in patients 6 years of age and older.
BREYNA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA).
Important Limitations of Use:
- BREYNA is NOT indicated for the relief of acute bronchospasm.
Maintenance Treatment of Chronic Obstructive Pulmonary Disease
BREYNA 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
BREYNA 160 mcg/4.5 mcg is also indicated to reduce exacerbations of COPD. BREYNA 160 mcg/4.5 mcg is the only strength indicated for the treatment of COPD.
Important Limitations of Use:
- BREYNA is NOT indicated for the relief of acute bronchospasm.
Source: DailyMed label, set id dc529fc4-bddb-4673-8202-dc401f86166f, version 5, effective November 15, 2025. NDC 0378-7502, one of 2 listings for this product.
Questions
What is Breyna used for?
The FDA label for Breyna lists 2 uses: Treatment of Asthma; Maintenance Treatment of Chronic Obstructive Pulmonary Disease.
What drug class is Breyna?
FDA lists budesonide and formoterol in the Corticosteroid and beta2-Adrenergic Agonist 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 0378-7503Breyna NDC record