Prescription medicine
Fluticasone and salmeterol Brand names: Advair, Airduo, Wixela; first approved as Advair Diskus 500/50
Fluticasone and salmeterol (Advair) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $1.07 per unit (Fluticasone-salmeterol 100-50) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $20.00 per gram (Advair hfa 45-21 mcg inhaler).
- Generic listed
- A presentation discontinued
Check it at the source: the fluticasone and salmeterol FDA label on DailyMed (effective March 26, 2026, GlaxoSmithKline LLC); the NDA 21077 record on Drugs@FDA; every fluticasone and salmeterol label on DailyMed.
Highlights of the record
FDA label of March 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageADVAIR 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.
Forms and strengths
Powder; powder (metered); aerosol (metered).
On the market
- Earliest approval on file
- August 24, 2000 Advair Diskus 500/50, Glaxo Grp Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first January 30, 2019; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 8 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- January 6, 2041 Airduo Respiclick powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.07 per unit Fluticasone-salmeterol 100-50
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 3 since 2012 0 Class I among all firms' recalls; latest January 26, 2022
- FAERS reports
- 100,237 through July 30, 2026
What is fluticasone and salmeterol used for?
From the label: indications and usageADVAIR 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. ( 1.1 )
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma ADVAIR DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. […]
Conditions named in the indications of fluticasone and salmeterol's FDA labels, with every medicine labeled for each:
From other fluticasone and salmeterol labelsCOPD: Treatment of Chronic Obstructive Pulmonary Disease ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic …
FDA pharmacologic class: Corticosteroid and beta2-Adrenergic Agonist.
Source: FDA drug label (ADVAIR DISKUS), GlaxoSmithKline LLC, effective March 26, 2026 (SPL set 4eeb5f6a-593f-4a9e-9692-adefa2caf8fc), via openFDA; the full label on DailyMed
Is there a generic for fluticasone and salmeterol (Advair)?
The FDA approved the first generic fluticasone and salmeterol on January 30, 2019. 5 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluticasone and salmeterol from 8 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Advair Diskus 100/50 powder; a patent listed only for Airduo Respiclick powder runs to January 6, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2019 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluticasone and salmeterol (Advair)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.07 per unit (Fluticasone-salmeterol 100-50), down 8% from $1.17 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluticasone-salmeterol 100-50 (generic)
- Advair hfa 45-21 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluticasone-salmeterol 100-50 | Generic | $1.07 per unit | n/a | -8% |
| Fluticasone-salmeterol 113-14 | Generic | $108.28 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -2% |
| Fluticasone-salmeterol 115-21 | Generic | $20.71 per gram | n/a | no change |
| Fluticasone-salmeterol 230-21 | Generic | $26.75 per gram | n/a | -2% |
| Fluticasone-salmeterol 232-14 | Generic | $105.32 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
| Fluticasone-salmeterol 250-50 | Generic | $1.25 per unit | n/a | -8% |
| Fluticasone-salmeterol 45-21 | Generic | $16.68 per gram | n/a | +2% |
| Fluticasone-salmeterol 500-50 | Generic | $1.64 per unit | n/a | -7% |
| Fluticasone-salmeterol 55-14 | Generic | $114.85 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Wixela 100-50 inhub | Generic | $1.07 per unit | n/a | -8% |
| Wixela 250-50 inhub | Generic | $1.25 per unit | n/a | -8% |
| Wixela 500-50 inhub | Generic | $1.64 per unit | n/a | -7% |
| Advair 100-50 diskus | Brand | $2.49 per unit | n/a | -0.1% |
| Advair 250-50 diskus | Brand | $3.12 per unit | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is fluticasone and salmeterol in shortage?
No fluticasone and salmeterol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated July 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Advair HFA, Aerosol, Metered, 115 ug; 21 ug (NDC 0173-0716-22) | GlaxoSmithKline | To Be Discontinued | July 27, 2026 |
| Advair HFA, Aerosol, Metered, 230 ug; 21 ug (NDC 0173-0717-22) | GlaxoSmithKline | To Be Discontinued | July 27, 2026 |
| Advair HFA, Aerosol, Metered, 45 ug; 21 ug (NDC 0173-0715-22) | GlaxoSmithKline | To Be Discontinued | July 27, 2026 |
Every fluticasone and salmeterol presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has fluticasone and salmeterol been recalled?
The FDA's Enforcement Report lists 3 recalls naming fluticasone and salmeterol since 2012: 0 Class I (the most serious), 1 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| October 24, 2012 | Class III | GlaxoSmithKline, LLC. | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluticasone and salmeterol label say about other medicines?
The fluticasone and salmeterol label names 13 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | Large doses of the related beta 2 -adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. |
| Atazanavir | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. |
| Budesonide | warnings and precautions | … Studies ( 14.1 )], 1 trial compared mometasone furoate/formoterol with mometasone furoate, and 1 trial compared budesonide/formoterol with budesonide. |
| Budesonide and formoterol | warnings and precautions | Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared fluticasone propionate/salmeterol inhalation powder (ADVAIR DISKUS) with fluticasone propionate inhalation powder [see Clinical Studies ( 14.1 )], 1 trial compared mometasone furoate/formoterol with mometasone furoate … |
| Clarithromycin | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. |
| Formoterol | warnings and precautions | … fluticasone propionate inhalation powder [see Clinical Studies ( 14.1 )], 1 trial compared mometasone furoate/formoterol with mometasone furoate, and 1 trial compared budesonide/formoterol with budesonide. |
| Itraconazole | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. |
| Ketoconazole | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. |
| Mometasone | warnings and precautions | Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared fluticasone propionate/salmeterol inhalation powder (ADVAIR DISKUS) with fluticasone propionate inhalation powder [see Clinical Studies ( 14.1 )], 1 trial compared mometasone furoate/formoterol with mometasone furoate … |
| Nefazodone | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. |
| Nelfinavir | drug interactions | The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. |
| Prednisone | warnings and precautions | Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. |
| Ritonavir | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. |
Source: FDA drug label (ADVAIR DISKUS), GlaxoSmithKline LLC, effective March 26, 2026 (SPL set 4eeb5f6a-593f-4a9e-9692-adefa2caf8fc), via openFDA; the full label on DailyMed
What do FAERS reports show for fluticasone and salmeterol?
The FDA Adverse Event Reporting System holds 100,237 reports that list fluticasone and salmeterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,575 are coded as a death and 26,464 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fluticasone and salmeterol?
19 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as fluticasone and salmeterol or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Albuterol | Asthma | 33 labelers | $0.0612 per mL 2.5 mg/3 mL solution | Resolved |
| Budesonide | Asthma | 13 labelers | $0.676 per mL 0.5 mg/2 mL suspension | No current entry |
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Budesonide and formoterol | Asthma, COPD | 2 labelers | $17.26 per gram 160-4.5 | No current entry |
| Arformoterol | COPD | 15 labelers | $0.633 per mL 15 mcg/2 mL solution | No current entry |
| Formoterol | COPD | 11 labelers | $1.30 per mL 20 mcg/2 mL neb vial | No current entry |
| Beclomethasone | Asthma | 2 labelers | $20.57 per gram 40 mcg | No current entry |
| Mometasone | Asthma | none listed | $6.84 per gram 50 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as fluticasone and salmeterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fluticasone and salmeterol compare with medicines for the same use?
2 side-by-side pages set fluticasone and salmeterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fluticasone and salmeterol
- 19 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluticasone and salmeterol side effects
- the label's list beside FAERS reports
- Fluticasone and salmeterol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other