Medicine
Levalbuterol 0.31 mg/3 mL inhalation solution
Levalbuterol 0.31 mg/3 mL inhalation solution is a generic prescription medicine for inhalation use, made by 9 labelers, 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 levalbuterol inhalation solution, USP in the protective foil pouch at…
Key facts
- Active ingredient (INN)
- Levalbuterol
- Brand
- Sold under the generic name
- Strength
- 0.31 mg/3 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 5 pouches, 2 pouches, 6 pouches and 10 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaRitedose PharmaceuticalsAmneal Pharmaceuticals of New YorkBryant Ranch PrepackBurel PharmaceuticalsLuoxin Aurovitas Pharma (Chengdu)Mylan PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store levalbuterol inhalation solution, USP in the protective foil pouch at 20° to 25°C (68° to 77°F). Protect from light and excessive heat. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week.
- 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
- 29 April 2013
- Identifiers
- RxCUI 242754, 311286, 349590DailyMed set ID 5f1c4f22-d420-495c-8f64-33532638215f, 5b4fa89e-aa46-4504-a275-246f3b4df1df, 2f416dc8-62aa-4b6b-a745-2c8a72bb763d +6NDC 65862-943, 0378-9690, 72162-2081 +6Application ANDA207625, ANDA203653, ANDA090297 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 5 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 65862-943-25 | Aurobindo PharmaIndia | 30 December 2016 |
| 5 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 47335-743-01 | Sun Pharmaceutical IndustriesIndia | 1 July 2020 |
| 2 pouch in 1 carton / 12 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 47335-743-49 | Sun Pharmaceutical IndustriesIndia | 1 December 2018 |
| 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 47335-743-52 | Sun Pharmaceutical IndustriesIndia | 1 December 2018 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 0115-9930-78 | Amneal Pharmaceuticals of New York | 17 February 2017 |
| 25 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 35573-443-25 | Burel Pharmaceuticals | 1 April 2021 |
| 5 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 81894-101-25 | Luoxin Aurovitas Pharma (Chengdu) | 30 December 2016 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 0378-9690-52 | Mylan Pharmaceuticals | 23 July 2018 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 76204-700-01 | Ritedose Pharmaceuticals | 17 February 2017 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 76204-700-25 | Ritedose Pharmaceuticals | 17 February 2017 |
| 5 pouch in 1 carton / 5 ampule in 1 pouch / 3 mL in 1 ampule | 76204-700-55 | Ritedose Pharmaceuticals | 17 February 2017 |
| 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 0093-4145-56 | Teva Pharmaceuticals | 7 January 2019 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 72162-2081-2 | Bryant Ranch Prepack | 13 September 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
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 Levalbuterol 0.31 mg/3 mL inhalation solution 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.