Medicine
Breyna 160 mcg/4.5 mcg inhaler
Breyna 160 mcg/4.5 mcg inhaler is a prescription medicine containing Budesonide and Formoterol for inhalation use, marketed by Mylan Pharmaceuticals, 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). For best results, the canister should be…
Key facts
- Active ingredient (INN)
- Budesonide and Formoterol
- Brand
- Breyna
- Strength
- 160 mcg/4.5 mcg
- Dosage form
- Inhaler
- Route
- Inhalation
- Packs
- 1 pouch
- Marketing authorisation holder
- Mylan Pharmaceuticals
- Manufacturer
- Mylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). For best results, the canister should be at room temperature before use. Store the inhaler with the mouthpiece down. Do not 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
- 31 July 2023
- Identifiers
- RxCUI 1246288, 1246304, 2597670 +1DailyMed set ID dc529fc4-bddb-4673-8202-dc401f86166fNDC 0378-7503Application ANDA211699
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 pouch in 1 carton / 1 canister in 1 pouch / 120 aerosol, metered in 1 canister | 0378-7503-32 | Mylan Pharmaceuticals | 31 July 2023 |
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 Budesonide and Formoterol 160 mcg/4.5 mcg inhaler.
Other strengths and forms of Budesonide and Formoterol
Clinical summary
Budesonide and Formoterol is a fixed-dose combination of a corticosteroid and a beta2-adrenergic agonist indicated for treatment of asthma in patients 6 years of age and older, among other approved uses. MedsAcross supplies Budesonide and Formoterol 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 Budesonide and FormoterolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SYMBICORT prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- BiResp Spiromax: European public assessment report (EPAR) · European Medicines Agency
- DuoResp Spiromax: European public assessment report (EPAR) · European Medicines Agency
Need Breyna 160 mcg/4.5 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.