Medicine
Budesonide and Formoterol 160 mcg/4.5 mcg inhaler
Budesonide and Formoterol 160 mcg/4.5 mcg inhaler is a generic prescription medicine for inhalation use, made by 4 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 controlled room temperature 20°C to 25°C (68°F to 77°F). For best…
Key facts
- Active ingredient (INN)
- Budesonide and Formoterol
- Brand
- Sold under the generic name
- Strength
- 160 mcg/4.5 mcg
- Dosage form
- Inhaler
- Route
- Inhalation
- Packs
- 1 pouch and 1 more
- Manufacturers
- A-S Medication SolutionsAstraZeneca PharmaceuticalsSportpharmTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F 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
- 3 January 2020
- Identifiers
- RxCUI 1246288, 1246304DailyMed set ID d6cc66c9-6f97-4ea8-a787-30a048004c77, 0ce4cd21-ac96-4b39-9e1c-49f86c87fa1a, 1d266fe8-52e3-4f85-a037-c5c1afa15e60 +1NDC 85766-114, 50090-6327, 0310-7370 +1Application NDA021929, ANDA212212
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 pouch in 1 carton / 1 canister in 1 pouch / 120 aerosol in 1 canister | 0310-7370-20 | AstraZeneca Pharmaceuticals | 3 January 2020 |
| 1 pouch in 1 carton / 1 canister in 1 pouch / 120 aerosol, metered in 1 canister | 0480-3081-31 | Teva Pharmaceuticals | 27 May 2026 |
| 1 pouch in 1 carton / 1 aerosol in 1 pouch | 50090-6327-0 | A-S Medication Solutions | 12 January 2023 |
| 1 pouch in 1 carton / 1 canister in 1 pouch / 120 aerosol in 1 canister | 85766-114-12 | Sportpharm | 31 October 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 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 Budesonide and Formoterol 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.