Medicine
Dulera 5 mcg/50 mcg inhaler
Dulera 5 mcg/50 mcg inhaler is a prescription medicine containing Formoterol and Mometasone furoate for inhalation use, marketed by Organon, 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 controlled room temperature 20°C–25°C (68°F–77°F), excursions…
Key facts
- Active ingredient (INN)
- Formoterol and Mometasone furoate
- Brand
- Dulera
- Strength
- 5 mcg/50 mcg
- Dosage form
- Inhaler
- Route
- Inhalation
- Packs
- 1 canister
- Marketing authorisation holder
- Organon
- Manufacturer
- Organon
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C–25°C (68°F–77°F), excursions permitted to 15°C–30°C (59°F–86°F). For best results, keep the canister at room temperature before use. Exposure to temperatures above 120°F may cause bursting. After priming, store the inhaler with the mouthpiece down or in a horizontal position. Do not use or store near heat or open flame.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03AK07 Budesonide and Formoterol
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2021
- Identifiers
- RxCUI 1246308, 1246310, 1246311 +7DailyMed set ID 8f399784-f257-4f31-b3dc-368bf2a1864dNDC 78206-125Application NDA022518
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 canister in 1 carton / 120 aerosol in 1 canister | 78206-125-01 | Organon | 1 June 2021 |
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
Other strengths and forms of Formoterol and Mometasone furoate
Clinical summary
Formoterol and Mometasone furoate is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for treatment of asthma in patients 5 years of age and older, among other approved uses. MedsAcross supplies Formoterol and Mometasone furoate 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 Formoterol and Mometasone furoateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dulera prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Dulera 5 mcg/50 mcg inhaler 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.