Medicine
Budesonide 3 mg capsule
Budesonide 3 mg capsule is a generic prescription medicine for oral use, made by 8 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Key facts
- Active ingredient (INN)
- Budesonide
- Brand
- Sold under the generic name
- Strength
- 3 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 17 more
- Manufacturers
- Zydus LifesciencesIndiaBryant Ranch PrepackAmerican Health PackagingGolden State Medical SupplyMajor PharmaceuticalsNorthStar RxPadagisRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°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
- 2 October 2001
- Identifiers
- RxCUI 1244214DailyMed set ID 33def4dc-b469-f987-e063-6294a90ace0b, 263303c2-8e4f-7b6c-e063-6394a90aef9e, 4a8e79df-3946-4e9a-b214-e9fdd824b565 +6NDC 72162-2473, 51407-591, 60687-596 +6Application NDA021324, ANDA206134
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, coated pellets in 1 bottle | 68382-720-01 | Zydus LifesciencesIndia | 8 June 2017 |
| 500 capsule, coated pellets in 1 bottle | 68382-720-05 | Zydus LifesciencesIndia | 8 June 2017 |
| 30 capsule, coated pellets in 1 bottle | 68382-720-06 | Zydus LifesciencesIndia | 8 June 2017 |
| 1000 capsule, coated pellets in 1 bottle | 68382-720-10 | Zydus LifesciencesIndia | 8 June 2017 |
| 90 capsule, coated pellets in 1 bottle | 68382-720-16 | Zydus LifesciencesIndia | 8 June 2017 |
| 10 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack | 68382-720-77 | Zydus LifesciencesIndia | 8 June 2017 |
| 1000 capsule, coated pellets in 1 bottle | 70771-1075-0 | Zydus LifesciencesIndia | 8 June 2017 |
| 100 capsule, coated pellets in 1 bottle | 70771-1075-1 | Zydus LifesciencesIndia | 8 June 2017 |
| 30 capsule, coated pellets in 1 bottle | 70771-1075-3 | Zydus LifesciencesIndia | 8 June 2017 |
| 10 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack | 70771-1075-4 | Zydus LifesciencesIndia | 8 June 2017 |
| 500 capsule, coated pellets in 1 bottle | 70771-1075-5 | Zydus LifesciencesIndia | 8 June 2017 |
| 90 capsule, coated pellets in 1 bottle | 70771-1075-9 | Zydus LifesciencesIndia | 8 June 2017 |
| 1 bottle in 1 carton / 100 capsule in 1 bottle | 0574-9855-10 | Padagis | 29 June 2018 |
| 20 blister pack in 1 box, unit-dose / 1 capsule, coated pellets in 1 blister pack | 60687-596-32 | American Health Packaging | 9 March 2021 |
| 1 bottle in 1 carton / 100 capsule in 1 bottle | 72162-2473-1 | Bryant Ranch Prepack | 24 April 2025 |
| 1 bottle in 1 carton / 100 capsule in 1 bottle | 72162-2473-2 | Bryant Ranch Prepack | 24 April 2025 |
| 100 capsule in 1 bottle | 51407-591-01 | Golden State Medical Supply | 24 October 2024 |
| 20 blister pack in 1 carton / 1 capsule, coated pellets in 1 blister pack | 0904-7313-10 | Major Pharmaceuticals | 3 September 2024 |
| 100 capsule, coated pellets in 1 bottle | 16714-829-01 | Northstar Rx | 25 June 2018 |
| 50 pouch in 1 box / 1 capsule, coated pellets in 1 pouch | 70518-4613-0 | Remedyrepack | 23 April 2026 |
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 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.