Medicine
Xopenex HFA 45 mcg aerosol
Xopenex HFA 45 mcg aerosol is a prescription medicine containing Levalbuterol for oral use, marketed by Lupin, 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
Protect from freezing temperatures and direct sunlight. Store between 20° and…
Key facts
- Active ingredient (INN)
- Levalbuterol
- Brand
- Xopenex HFA
- Strength
- 45 mcg
- Dosage form
- Aerosol
- Route
- Oral
- Packs
- 1 inhaler
- Marketing authorisation holder
- Lupin
- Manufacturer
- LupinIndia
- Origin register
- US FDA, United States
- Storage
- Protect from freezing temperatures and direct sunlight. Store between 20° and 25°C (68° and 77°F, see USP controlled room temperature). Exposure to temperatures above 120°F may cause bursting. Store inhaler with the actuator mouthpiece down. Do not 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
- 10 November 2023
- Identifiers
- RxCUI 745791, 746466DailyMed set ID 70a35706-d7a8-4a48-98c6-1cab1c42fe8dNDC 27437-056Application NDA021730
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 / 200 aerosol, metered in 1 inhaler | 27437-056-01 | LupinIndia | 10 November 2023 |
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 March 1999 | 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
Alternatives
Other makers and brands of Levalbuterol 45 mcg aerosol.
Other strengths and forms of Levalbuterol
Clinical summary
Levalbuterol is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. It is available as inhalation solution and aerosol for oral use. MedsAcross supplies Levalbuterol 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 LevalbuterolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XOPENEX HFA prescribing information (Lupin) · U.S. National Library of Medicine, DailyMed
Need Xopenex HFA 45 mcg aerosol 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.