Quick answers
- What is Breyna?
- Breyna is a brand name of Budesonide and formoterol fumarate dihydrate, a prescription medicine. The FDA NDC Directory lists 2 Breyna products in 2 strengths and forms.
- Who makes Breyna?
- Mylan holds the FDA application for Breyna (ANDA211699, approved March 15, 2022).
- Is there a generic or store brand of Breyna?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Breyna product, 2 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Breyna?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Breyna strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Breyna been recalled?
- No recall linked to Breyna products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Breyna is
Each Breyna product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Budesonide and formoterol fumarate dihydrate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| budesonide 160 ug · formoterol fumarate 4.5 ug aerosol, metered (respiratory (inhalation)) | Breyna | 1 product, 1 company | DailyMed |
| budesonide 80 ug · formoterol fumarate 4.5 ug aerosol, metered (respiratory (inhalation)) | Breyna | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Budesonide and formoterol fumarate dihydrate →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA211699 | Mylan | March 15, 2022 | 2 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| budesonide 160 ug · formoterol fumarate 4.5 ug aerosol, metered | Generic: Breyna | $20.53 per gram Generic of the same strength and form: $17.32–$20.53 per gram |
| budesonide 80 ug · formoterol fumarate 4.5 ug aerosol, metered | Generic: Breyna | $17.71 per gram Generic of the same strength and form: $15.53–$17.71 per gram |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Breyna
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Breyna products.
- Mylan Pharmaceuticals Inc.2 products
Recalls
No recall linked to Breyna products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.