Medicine
Pulmicort Respules 0.5 mg/2 mL inhalation suspension
Pulmicort Respules 0.5 mg/2 mL inhalation suspension is a prescription medicine containing Budesonide for inhalation use, marketed by AstraZeneca Pharmaceuticals, 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. PULMICORT RESPULES is available in three strengths, each…
Key facts
- Active ingredient (INN)
- Budesonide
- Brand
- Pulmicort Respules
- Strength
- 0.5 mg/2 mL
- Dosage form
- Inhalation suspension
- Route
- Inhalation
- Packs
- 6 pouches
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. PULMICORT RESPULES is available in three strengths, each containing 2 mL: NDC 0186–1988–04 0.25 mg/2 mL NDC 0186–1989–04 0.5 mg/2 mL NDC 0186–1990–04 1 mg/2 mL PULMICORT RESPULES should be stored upright at controlled room temperature 20-25°C (68-77°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
- 8 September 2000
- Identifiers
- RxCUI 252559, 349094, 351109 +3DailyMed set ID 33cd9834-76df-4f26-3fa2-aab6b9eee8f2NDC 0186-1989Application NDA020929
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 |
|---|---|---|---|
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 2 mL in 1 ampule | 0186-1989-04 | AstraZeneca Pharmaceuticals | 8 September 2000 |
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 inhalation suspension.
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 Respules 0.5 mg/2 mL inhalation suspension 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.