Medicine
Breztri 160 mcg/4.8 mcg/9 mcg inhaler
Breztri 160 mcg/4.8 mcg/9 mcg inhaler is a prescription medicine containing Budesonide, Formoterol and Glycopyrrolate 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Budesonide, Formoterol and Glycopyrrolate
- Brand
- Breztri
- Strength
- 160 mcg/4.8 mcg/9 mcg
- Dosage form
- Inhaler
- Route
- Inhalation
- Packs
- 120 aerosol, 28 aerosol
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 July 2020
- Identifiers
- NDC 0310-4616Application NDA212122
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 |
|---|---|---|---|
| 120 aerosol, metered in 1 inhaler | 0310-4616-12 | AstraZeneca Pharmaceuticals | 23 July 2020 |
| 28 aerosol, metered in 1 inhaler | 0310-4616-39 | AstraZeneca Pharmaceuticals | 23 July 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 23 July 2020 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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, Formoterol and Glycopyrrolate
Clinical summary
Clinical information for Budesonide, Formoterol and Glycopyrrolate is on its overview page.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Budesonide, Formoterol and GlycopyrrolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- US FDA NDC directory · Checked 12 November 2026
Need Breztri 160 mcg/4.8 mcg/9 mcg inhaler 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.