Medicine
Bevespi Aerosphere 4.8 mcg/9 mcg inhaler
Bevespi Aerosphere 4.8 mcg/9 mcg inhaler is a prescription medicine containing 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
Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Formoterol and Glycopyrrolate
- Brand
- Bevespi Aerosphere
- Strength
- 4.8 mcg/9 mcg
- Dosage form
- Inhaler
- Route
- Inhalation
- Packs
- 120 aerosol
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). For best results, the canister should be at room temperature before use. Exposure to temperatures above 49°C (120°F) may cause bursting. Do not use or store near heat or open flame.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 October 2016
- Identifiers
- RxCUI 1790639, 1790644DailyMed set ID ae02436e-9528-490e-a844-0c0f6f2843f9NDC 0310-4600Application NDA208294
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 | 0310-4600-12 | AstraZeneca Pharmaceuticals | 3 October 2016 |
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 25 April 2016 | 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
Clinical summary
Formoterol and Glycopyrrolate is a fixed-dose combination of an anticholinergic, a cholinergic muscarinic antagonist and a beta2-adrenergic agonist indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), among other approved uses. MedsAcross supplies Formoterol and Glycopyrrolate 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 Formoterol and GlycopyrrolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BEVESPI AEROSPHERE prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Bevespi Aerosphere 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.