Quick answers
- What is Levalbuterol used for?
- The FDA-approved label (Xopenex HFA, Lupin Pharmaceuticals, Inc., June 2, 2025) says: “XOPENEX HFA is a beta 2 -adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.1 Bronchospasm XOPENEX HFA is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levalbuterol have a boxed warning?
- The label we quote has no boxed warning, but 3 of 20 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Levalbuterol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levalbuterol been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Levalbuterol?
- 14 companies list prescription products of Levalbuterol in the FDA NDC Directory, including Aurobindo Pharma Limited, Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA, Inc..
What Levalbuterol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XOPENEX HFA is a beta 2 -adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.1 Bronchospasm XOPENEX HFA is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.
— FDA label: Xopenex HFA, Lupin Pharmaceuticals, Inc., effective June 2, 2025. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
3 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Aerosol, metered · Solution, concentrate |
|---|---|
| Route | Respiratory (inhalation) · Oral |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Xopenex HFA |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| levalbuterol hydrochloride 0.31 mg/3 mL solution | Generic | $0.2549–$0.2966 per mL 6 packages, lowest to highest |
| levalbuterol hydrochloride 0.63 mg/3 mL solution | Generic | $0.2549–$0.3028 per mL 6 packages, lowest to highest |
| levalbuterol hydrochloride 1.25 mg/0.5 mL solution, concentrate | Generic | $5.22 per unit |
| levalbuterol hydrochloride 1.25 mg/3 mL solution | Generic | $0.2736–$0.3772 per mL 6 packages, lowest to highest |
| levalbuterol tartrate 45 ug aerosol, metered | Generic | $3.55 per gram |
| levalbuterol tartrate 45 ug aerosol, metered | Brand: Xopenex HFA | $4.98 per gram |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aurobindo Pharma Limited4 products
- Mylan Pharmaceuticals Inc.4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Ritedose Pharmaceuticals, LLC3 products
- Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.3 products
- Burel Pharmaceuticals, LLC3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Bryant Ranch Prepack3 products
- Redpharm Drug2 products
- Proficient Rx LP2 products
- A-S Medication Solutions1 product
- Actavis Pharma, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021730 XOPENEX HFA | Lupin | March 11, 2005 | 13, latest February 27, 2017 2017: Labeling · 2016: Manufacturing (CMC) · 2015: Efficacy |
Generic approvals (6)
- ANDA078309Mylan Speciality LP · March 20, 2009
- ANDA090297Teva Pharms USA · April 26, 2013
- ANDA203653Ritedose Corp · March 22, 2016
- ANDA207625Luoxin Aurovitas · December 30, 2016
- ANDA207628Luoxin Aurovitas · January 31, 2017
- ANDA207820Sun Pharm · November 5, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1067-2022
cGMP deviations: Temperature abuse
Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54 — Mckesson Medical-Surgical Inc. Corporate Office
-
March 15, 2021 · Class II · Terminated · D-0580-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xopenex HFA, Lupin Pharmaceuticals, Inc., effective June 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →