Quick answers
- What is Fluticasone furoate and vilanterol trifenatate used for?
- The FDA-approved label (Breo Ellipta, GlaxoSmithKline LLC, November 7, 2024) says: “BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 5 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluticasone furoate and vilanterol trifenatate have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluticasone furoate and vilanterol trifenatate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluticasone furoate and vilanterol trifenatate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fluticasone furoate and vilanterol trifenatate?
- 2 companies list prescription products of Fluticasone furoate and vilanterol trifenatate in the FDA NDC Directory, including GlaxoSmithKline LLC and Prasco Laboratories.
What Fluticasone furoate and vilanterol trifenatate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 5 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm. …
— FDA label: Breo Ellipta, GlaxoSmithKline LLC, effective November 7, 2024. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Powder |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Breo Ellipta |
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 | Generic | $3.82 per unit |
| fluticasone furoate 100 ug · vilanterol trifenatate 25 ug powder | Brand: Breo Ellipta | $5.36–$6.50 per unit 2 packages, lowest to highest |
| fluticasone furoate 200 ug · vilanterol trifenatate 25 ug powder | Generic | $3.89 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 |
| 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- GlaxoSmithKline LLC3 products
- Prasco Laboratories2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204275 BREO ELLIPTA | Glaxo Grp Ltd | May 10, 2013 | 11, latest May 12, 2023 2023: Efficacy · 2019: Labeling · 2017: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Breo Ellipta, GlaxoSmithKline LLC, effective November 7, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →