Medicine
Budesonide 9 mg extended-release tablet
Budesonide 9 mg extended-release tablet is a generic prescription medicine for oral use, made by 3 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). Protect from light and moisture.
Key facts
- Active ingredient (INN)
- Budesonide
- Brand
- Sold under the generic name
- Strength
- 9 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets
- Manufacturers
- Actavis PharmaMylan PharmaceuticalsOceanside Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EA06 Budesonide
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 July 2018
- Identifiers
- RxCUI 1366550DailyMed set ID 41d4fd39-81ee-41be-b34d-efb12b3a359d, f7265276-e649-4bc4-8ac8-1f5ac2b984e8, a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1NDC 0591-2510, 0378-4500, 68682-309Application ANDA205457, ANDA208851, NDA203634
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 |
|---|---|---|---|
| 30 tablet, film coated, extended release in 1 bottle | 0591-2510-30 | Actavis Pharma | 5 July 2018 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 0378-4500-93 | Mylan Pharmaceuticals | 21 October 2020 |
| 30 tablet, extended release in 1 bottle | 68682-309-30 | Oceanside Pharmaceuticals | 10 July 2018 |
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 9 mg extended-release tablet.
Other strengths and forms of Budesonide
Clinical summary
Budesonide is a corticosteroid indicated for maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age, among other approved uses. MedsAcross supplies Budesonide 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 BudesonideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PULMICORT RESPULES prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Jorveza: European public assessment report (EPAR) · European Medicines Agency
- Kinpeygo: European public assessment report (EPAR) · European Medicines Agency
Need Budesonide 9 mg extended-release tablet 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.