Medicine
Budesonide 3 mg delayed-release capsule
Budesonide 3 mg delayed-release capsule 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), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Budesonide
- Brand
- Sold under the generic name
- Strength
- 3 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 100 capsules, 180 capsules, 300 capsules and 3 more
- Manufacturers
- Amneal PharmaceuticalsAmneal Pharmaceuticals of New YorkBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- 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
- 15 September 2017
- Identifiers
- RxCUI 1244214DailyMed set ID b15102d5-7884-44ed-8340-046d7b516fa8, 10336e42-0e9d-45c4-80bc-5149d5ec9e1c, 4943ef5b-f48b-49d6-b419-467f71ef64e0NDC 65162-778, 53746-778, 63629-8294Application ANDA206200
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 |
|---|---|---|---|
| 100 capsule, delayed release in 1 bottle | 65162-778-10 | Amneal Pharmaceuticals | 15 September 2017 |
| 180 capsule, delayed release in 1 bottle | 65162-778-18 | Amneal Pharmaceuticals | 15 September 2017 |
| 300 capsule, delayed release in 1 bottle | 65162-778-30 | Amneal Pharmaceuticals | 15 September 2017 |
| 21 capsule, delayed release in 1 bottle | 65162-778-49 | Amneal Pharmaceuticals | 15 September 2017 |
| 100 capsule, delayed release in 1 bottle | 53746-778-10 | Amneal Pharmaceuticals of New York | 22 May 2025 |
| 30 capsule, delayed release in 1 bottle | 63629-8294-1 | Bryant Ranch Prepack | 6 February 2020 |
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 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 3 mg delayed-release capsule 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.