Medicine
Pulmicort Flexhaler 180 mcg inhalation powder
Pulmicort Flexhaler 180 mcg inhalation powder is a prescription medicine containing Budesonide for inhalation use, marketed by H2-Pharma, 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 in a dry place at controlled room temperature 20-25°C (68-77°F) with the…
Key facts
- Active ingredient (INN)
- Budesonide
- Brand
- Pulmicort Flexhaler
- Strength
- 180 mcg
- Dosage form
- Inhalation powder
- Route
- Inhalation
- Packs
- 1 inhaler and 2 more
- Marketing authorisation holder
- H2-Pharma
- Manufacturers
- H2-PharmaA-S Medication SolutionsRubicon Holdings
- Origin register
- US FDA, United States
- Storage
- Store in a dry place at controlled room temperature 20-25°C (68-77°F) with the cover tightly in place.
- 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
- 19 March 2007
- Identifiers
- RxCUI 966522, 966524, 966527 +1DailyMed set ID 79fc8cf4-bb33-4892-9dd2-641d7e943a01, 10ea5d87-6ed0-4fa5-a37b-2043c8560bc0, 10f2ae5b-a6fb-4804-9111-0cd067c2b1b2 +2NDC 50090-2239, 50090-6796, 61269-518 +2Application NDA021949
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 inhaler in 1 carton / 120 aerosol, powder in 1 inhaler | 61269-518-12 | H2-Pharma | 19 March 2007 |
| 1 inhaler in 1 carton / 120 aerosol, powder in 1 inhaler | 85612-011-01 | Rubicon Holdings | 14 August 2025 |
| 1 inhaler in 1 carton / 120 aerosol, powder in 1 inhaler | 50090-2239-0 | A-S Medication Solutions | 23 November 2015 |
| 1 inhaler in 1 carton / 120 aerosol, powder in 1 inhaler | 50090-6796-0 | A-S Medication Solutions | 1 November 2023 |
| 1 inhaler in 1 carton / 120 aerosol, powder in 1 inhaler | 50090-7867-0 | A-S Medication Solutions | 27 January 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 Pulmicort Flexhaler 180 mcg inhalation powder 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.