Quick answers
- What is Fluticasone propionate and salmeterol used for?
- The FDA-approved label (Fluticasone Propionate and Salmeterol DISKUS, Remedyrepack Inc., September 8, 2026) says: “Fluticasone Propionate/Salmeterol DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Twice-daily treatment of asthma in patients aged 4 years and older. Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important limitation of use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluticasone propionate and salmeterol have a boxed warning?
- No. None of the 29 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluticasone propionate and salmeterol?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated July 27, 2026). Ask your pharmacist about alternatives.
- Has Fluticasone propionate and salmeterol been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started January 26, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fluticasone propionate and salmeterol?
- 14 companies list prescription products of Fluticasone propionate and salmeterol in the FDA NDC Directory, including A-S Medication Solutions, Teva Pharmaceuticals USA, Inc. and GlaxoSmithKline LLC.
What Fluticasone propionate and salmeterol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fluticasone Propionate/Salmeterol DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Twice-daily treatment of asthma in patients aged 4 years and older. Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important limitation of use …
— FDA label: Fluticasone Propionate and Salmeterol DISKUS, Remedyrepack Inc., effective September 8, 2026. Read the full label on DailyMed →
The FDA has 29 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 29 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Powder · Powder, metered · Aerosol, metered |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 60 in the FDA NDC Directory |
| Brand names | Fluticasone Propionate and Salmeterol Diskus, Advair Diskus, Advair HFA, Wixela Inhub, Airduo Respiclick |
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 propionate 100 ug · salmeterol xinafoate 50 ug powder | Generic | $1.01 per unit |
| fluticasone propionate 100 ug · salmeterol xinafoate 50 ug powder | Brand: Advair Diskus | $2.49 per unit |
| fluticasone propionate 113 ug · salmeterol xinafoate 14 ug powder, metered | Generic | $103.65 per unit |
| fluticasone propionate 115 ug · salmeterol xinafoate 21 ug aerosol, metered | Generic | $20.59 per gram |
| fluticasone propionate 115 ug · salmeterol xinafoate 21 ug aerosol, metered | Brand: Advair HFA | $18.75–$25.39 per gram 2 packages, lowest to highest |
| fluticasone propionate 230 ug · salmeterol xinafoate 21 ug aerosol, metered | Generic | $27.15 per gram |
| fluticasone propionate 230 ug · salmeterol xinafoate 21 ug aerosol, metered | Brand: Advair HFA | $30.53–$35.01 per gram 2 packages, lowest to highest |
| fluticasone propionate 232 ug · salmeterol xinafoate 14 ug powder, metered | Generic | $106.55 per unit |
| fluticasone propionate 250 ug · salmeterol xinafoate 50 ug powder | Generic | $1.21 per unit |
| fluticasone propionate 250 ug · salmeterol xinafoate 50 ug powder | Brand: Advair Diskus | $3.12 per unit |
| fluticasone propionate 45 ug · salmeterol xinafoate 21 ug aerosol, metered | Generic | $16.54 per gram |
| fluticasone propionate 45 ug · salmeterol xinafoate 21 ug aerosol, metered | Brand: Advair HFA | $19.97–$20.02 per gram 2 packages, lowest to highest |
| fluticasone propionate 500 ug · salmeterol xinafoate 50 ug powder | Generic | $1.62 per unit |
| fluticasone propionate 500 ug · salmeterol xinafoate 50 ug powder | Brand: Advair Diskus | $4.23 per unit |
| fluticasone propionate 55 ug · salmeterol xinafoate 14 ug powder, metered | Generic | $114.53 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.
- A-S Medication Solutions14 products
- Teva Pharmaceuticals USA, Inc.6 products
- GlaxoSmithKline LLC6 products
- Prasco Laboratories6 products
- Remedyrepack Inc.5 products
- Bryant Ranch Prepack4 products
- Teva Respiratory, LLC3 products
- Mylan Pharmaceuticals Inc.3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Cipla USA Inc.3 products
- Lannett Company, Inc.2 products
- Sportpharm LLC2 products
- Preferred Pharmaceuticals Inc.2 products
- Proficient Rx LP1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021077 ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, ADVAIR DISKUS 500/50 | Glaxo Grp Ltd | August 24, 2000 | 28, latest January 7, 2019 2019: Labeling · 2017: Efficacy · 2017: Efficacy |
| NDA021254 ADVAIR HFA | Glaxo Grp Ltd | June 8, 2006 | 19, latest August 18, 2021 2021: Labeling · 2019: Labeling · 2017: Labeling |
| NDA208799 AIRDUO DIGIHALER, AIRDUO RESPICLICK | Teva Pharm | January 27, 2017 | 6, latest November 16, 2023 2023: Labeling · 2022: Labeling · 2021: Efficacy |
Generic approvals (5)
- ANDA208891Mylan · January 30, 2019
- ANDA203433Hikma · December 17, 2020
- ANDA213948Teva Pharms USA · December 13, 2021
- ANDA214464Respirent Pharms · January 12, 2026
- ANDA213087Cipla · July 27, 2026
Shortage status
To be discontinued · updated July 27, 2026 · first posted July 27, 2026
| Product | Advair HFA, Aerosol, Metered, 45 ug; 21 ug (NDC 0173-0715-22) |
|---|---|
| Company | GlaxoSmithKline |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
January 26, 2022 · Class II · Terminated · D-0202-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32 — CARDINAL HEALTHCARE
-
October 24, 2012 · Class III · Terminated · D-065-2013
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. — GlaxoSmithKline, LLC.
-
October 24, 2012 · Class III · Terminated · D-064-2013
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27 — GlaxoSmithKline, LLC.
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
| RxCUI (RxNorm) | 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222 … (+10) |
|---|---|
| SPL set ID of the quoted label | 1ce604aa-2535-4a3c-a64d-092f5d4f8194 |
| FDA labels (SPL) | 29 |
| FDA applications | NDA021077, NDA021254, NDA208799, 5 ANDA |
| Active ingredients (FDA) | FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fluticasone Propionate and Salmeterol DISKUS, Remedyrepack Inc., effective September 8, 2026; 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 →