Active substance
Levosalbutamol
- US FDA 14
- US price lines 7
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| XOPENEX HFA | EQ 0.045MG BASE/INH | aerosol, metered · inhalation | LUPIN | Prescription | 11 Mar 2005 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE; EQ 0.042% BASE; EQ 0.0103% BASE | solution · inhalation | IMPAX LABS INC | Prescription | 9 Apr 2008 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | solution · inhalation | MYLAN SPECIALITY LP | Prescription | 20 Mar 2009 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | TEVA PHARMS USA | Prescription | 26 Apr 2013 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | CIPLA | Prescription | 13 Dec 2013 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | solution · inhalation | TEVA PARENTERAL | Prescription | 11 Sep 2014 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | RITEDOSE CORP | Prescription | 22 Mar 2016 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | LUOXIN AUROVITAS | Prescription | 30 Dec 2016 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | solution · inhalation | LUOXIN AUROVITAS | Prescription | 31 Jan 2017 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | NEPHRON | Prescription | 26 May 2026 |
| XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · inhalation | HIKMA PHARMS | Discontinued | 25 Mar 1999 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | PHARMOBEDIENT | Discontinued | 15 Mar 2013 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | SUN PHARM | Discontinued | 5 Nov 2018 |
| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE; EQ 0.021% BASE; EQ 0.042% BASE | solution · inhalation | MANKIND PHARMA | Discontinued | 21 Oct 2024 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LEVALBUTEROL 0.31 MG/3 ML SOL | $0.31404 | per ML | 23 Sep 2026 |
| US NADAC | LEVALBUTEROL 0.31 MG/3 ML SOL | $0.26246 | per ML | 23 Sep 2026 |
| US NADAC | LEVALBUTEROL 0.63 MG/3 ML SOL | $0.31237 | per ML | 23 Sep 2026 |
| US NADAC | LEVALBUTEROL 0.63 MG/3 ML SOL | $0.24802 | per ML | 23 Sep 2026 |
| US NADAC | LEVALBUTEROL 1.25 MG/3 ML SOL | $0.38973 | per ML | 23 Sep 2026 |
| US NADAC | LEVALBUTEROL 1.25 MG/3 ML SOL | $0.27307 | per ML | 23 Sep 2026 |
| US NADAC | XOPENEX HFA 45 MCG INHALER | $4.98775 | per GM | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 3 Jan 2019 XOPENEX — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Feb 2017 XOPENEX HFA — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.