Medicine
Fluticasone propionate and Salmeterol 100 mcg/50 mcg inhalation powder
Fluticasone propionate and Salmeterol 100 mcg/50 mcg inhalation powder is a generic prescription medicine for inhalation use, made by 6 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F). Store in a dry place away from direct heat…
Key facts
- Active ingredient (INN)
- Fluticasone propionate and Salmeterol
- Brand
- Sold under the generic name
- Strength
- 100 mcg/50 mcg
- Dosage form
- Inhalation powder
- Route
- Inhalation
- Packs
- 1 inhaler, 1 pouch and 3 more
- Manufacturers
- CiplaIndiaHikma PharmaceuticalsLannettPreferred PharmaceuticalsRemedyrepackTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store in a dry place away from direct heat or sunlight. Fluticasone propionate and salmeterol inhalation powder should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03AK06 Fluticasone propionate and Salmeterol
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 December 2020
- Identifiers
- RxCUI 896184, 896209, 896228DailyMed set ID 7fdaa6db-82bd-4941-be11-ee80a0784d55, ce347bf4-4cc1-46dc-b5f1-6f8ff48da84b, f9fcfc90-3677-4a9b-900e-44417d50d507 +3NDC 70518-4406, 0093-7517, 0054-0326 +3Application ANDA203433, ANDA213948, ANDA213087 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 inhaler in 1 carton / 60 powder in 1 inhaler | 69097-662-03 | CiplaIndia | 27 July 2026 |
| 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder in 1 inhaler | 0054-0326-56 | Hikma Pharmaceuticals | 17 December 2020 |
| 1 inhaler in 1 carton / 60 powder in 1 inhaler | 0527-6010-06 | Lannett | 12 January 2026 |
| 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder in 1 inhaler | 0093-7517-31 | Teva Pharmaceuticals | 23 March 2022 |
| 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder in 1 inhaler | 68788-8704-6 | Preferred Pharmaceuticals | 28 June 2024 |
| 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder in 1 inhaler | 70518-4406-0 | Remedyrepack | 27 July 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fluticasone propionate and Salmeterol 100 mcg/50 mcg inhalation powder.
- Fluticasone Propionate and Salmeterol DISKUS 100 mcg/50 mcg inhalation powderAvailable on requestA-S Medication SolutionsUS FDA3 packs
- Advair Diskus 100 mcg/50 mcg inhalation powderAvailable on requestGlaxoSmithKlineUS FDA3 packs
- Wixela Inhub 100 mcg/50 mcg inhalation powderAvailable on requestMylan PharmaceuticalsUS FDA1 pack
Other strengths and forms of Fluticasone propionate and Salmeterol
Clinical summary
Fluticasone propionate and Salmeterol is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for twice-daily treatment of asthma in patients aged 4 years and older, among other approved uses. MedsAcross supplies Fluticasone propionate and Salmeterol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Fluticasone propionate and SalmeterolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ADVAIR DISKUS prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
- Seffalair Spiromax: European public assessment report (EPAR) · European Medicines Agency
Need Fluticasone propionate and Salmeterol 100 mcg/50 mcg inhalation powder for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.