Quick answers
- What is Salmeterol xinafoate used for?
- The FDA-approved label (Serevent Diskus, GlaxoSmithKline LLC, October 10, 2022) says: “SEREVENT DISKUS is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Important limitation 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 Salmeterol xinafoate have a boxed warning?
- Yes. The FDA label for Serevent Diskus has a boxed warning (“WARNING: ASTHMA-RELATED DEATH”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Salmeterol xinafoate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Salmeterol xinafoate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Salmeterol xinafoate?
- 1 company lists prescription products of Salmeterol xinafoate in the FDA NDC Directory, including GlaxoSmithKline LLC.
What Salmeterol xinafoate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SEREVENT DISKUS is a LABA indicated for: • Treatment of asthma in patients aged 4 years and older with an ICS. • Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. • Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Important limitation of use: Not indicated for relief of acute bronchospasm. …
— FDA label: Serevent Diskus, GlaxoSmithKline LLC, effective October 10, 2022. 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.
This label has a boxed warning. Its heading: WARNING: ASTHMA-RELATED DEATH
. Read it on the full label →
Forms and how it is given
| Dosage forms | Powder, metered |
|---|---|
| Route | Oral · Respiratory (inhalation) |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Serevent Diskus |
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 |
|---|---|---|
| salmeterol xinafoate 50 ug powder, metered | Brand: Serevent Diskus | $6.74 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 LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020692 SEREVENT | Glaxosmithkline | September 19, 1997 | 35, latest July 22, 2019 2019: Labeling · 2018: Labeling · 2016: 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
| RxCUI (RxNorm) | 866048, 866049 |
|---|---|
| SPL set ID of the quoted label | 12d9728e-6b5c-4aee-bfb0-745e542ed2e4 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020692 |
| Active ingredients (FDA) | SALMETEROL XINAFOATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Serevent Diskus, GlaxoSmithKline LLC, effective October 10, 2022; 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 →