Quick answers
- What is Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate used for?
- The FDA-approved label (Trelegy Ellipta, GlaxoSmithKline LLC, June 2, 2023) says: “TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; 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 18 years and older. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluticasone furoate, umeclidinium bromide 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, umeclidinium bromide and vilanterol trifenatate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate?
- 1 company lists prescription products of Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate in the FDA NDC Directory, including GlaxoSmithKline LLC.
What Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; 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 18 years and older. Limitations of Use …
— FDA label: Trelegy Ellipta, GlaxoSmithKline LLC, effective June 2, 2023. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Powder |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Trelegy 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 · umeclidinium bromide 62.5 ug · vilanterol trifenatate 25 ug powder | Brand: Trelegy Ellipta | $11.09–$11.15 per unit 2 packages, lowest to highest |
| fluticasone furoate 200 ug · umeclidinium bromide 62.5 ug · vilanterol trifenatate 25 ug powder | Brand: Trelegy Ellipta | $11.15–$11.20 per unit 2 packages, lowest to highest |
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 LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209482 TRELEGY ELLIPTA | Glaxosmithkline | September 18, 2017 | 9, latest June 2, 2023 2023: Labeling · 2022: Labeling · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0482-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research T — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0481-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Trelegy Ellipta, GlaxoSmithKline LLC, effective June 2, 2023; 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 →