Medicine
Budesonide 0.5 mg/2 mL inhalant
Budesonide 0.5 mg/2 mL inhalant 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
Do not freeze. Each single-dose ampule contains 2 mL of sterile liquid…
Key facts
- Active ingredient (INN)
- Budesonide
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/2 mL
- Dosage form
- Inhalant
- Route
- Oral
- Packs
- 30 pouches, 6 pouches and 1 more
- Manufacturers
- CiplaIndiaExelan PharmaceuticalsPreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Each single-dose ampule contains 2 mL of sterile liquid suspension Budesonide inhalation suspension is available in three strengths, each containing 2 mL: Budesonide Inhalation Suspension, 0.5 mg/2 mL 30 ampoules per carton 68788-7314-3 Budesonide inhalation suspension should be stored upright at controlled room temperature 20 to 25°C (68 to 77°F), and protected from light.
- 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
- 16 November 2017
- Identifiers
- RxCUI 351109, 252559, 349094DailyMed set ID dcb35488-23c5-4e7b-ab86-8406cf855748, c52c5382-1400-44b9-95be-a30e1cf706da, d9656442-4587-4867-9a8c-5f5b0402936eNDC 68788-7314, 69097-319, 76282-641Application ANDA205710
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 pouch in 1 carton / 1 ampule in 1 pouch / 2 mL in 1 ampule | 69097-319-53 | CiplaIndia | 10 April 2020 |
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 2 mL in 1 ampule | 69097-319-87 | CiplaIndia | 16 November 2017 |
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 2 mL in 1 ampule | 76282-641-38 | Exelan Pharmaceuticals | 17 April 2019 |
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 2 mL in 1 ampule | 68788-7314-3 | Preferred Pharmaceuticals | 2 January 2019 |
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 2 mL in 1 ampule | 0487-9701-01 | — | 1 October 2013 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 2 mL in 1 ampule | 0487-9701-30 | — | 1 October 2013 |
| 30 pouch in 1 carton / 5 ampule in 1 pouch / 2 mL in 1 ampule | 64980-639-03 | — | 14 March 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 0.5 mg/2 mL inhalant.
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 0.5 mg/2 mL inhalant 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.