Quick answers
- What is Breo Ellipta?
- Breo Ellipta is a brand name of Fluticasone furoate and vilanterol trifenatate, a prescription medicine. The FDA NDC Directory lists 3 Breo Ellipta products in 3 strengths and forms.
- Who makes Breo Ellipta?
- Glaxo GRP Ltd holds the FDA application for Breo Ellipta (NDA204275, approved May 10, 2013).
- Is there a generic or store brand of Breo Ellipta?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Breo Ellipta product, 2 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Breo Ellipta?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 3 Breo Ellipta 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 Breo Ellipta been recalled?
- No recall linked to Breo Ellipta products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Breo Ellipta is
Each Breo Ellipta 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.
Fluticasone furoate and vilanterol trifenatate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| fluticasone furoate 100 ug · vilanterol trifenatate 25 ug powder (respiratory (inhalation)) | Breo Ellipta | 1 product, 1 company | DailyMed |
| fluticasone furoate 200 ug · vilanterol trifenatate 25 ug powder (respiratory (inhalation)) | Breo Ellipta | 1 product, 1 company | DailyMed |
| fluticasone furoate 50 ug · vilanterol trifenatate 25 ug powder (respiratory (inhalation)) | Breo Ellipta | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Fluticasone furoate and vilanterol trifenatate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA204275 | Glaxo GRP Ltd | May 10, 2013 | 3 |
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 |
|---|---|---|
| fluticasone furoate 100 ug · vilanterol trifenatate 25 ug powder | Brand: Breo Ellipta | $5.36–$6.50 per unit 2 packages, lowest to highest Generic of the same strength and form: $3.82 per unit |
| fluticasone furoate 200 ug · vilanterol trifenatate 25 ug powder | Brand: Breo Ellipta | $5.35–$6.50 per unit 2 packages, lowest to highest Generic of the same strength and form: $3.89 per unit |
| fluticasone furoate 50 ug · vilanterol trifenatate 25 ug powder | Brand: Breo Ellipta | $6.48 per unit |
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 Breo Ellipta
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Breo Ellipta products.
- GlaxoSmithKline LLC3 products
Recalls
No recall linked to Breo Ellipta 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.