Prescription medicine
Levalbuterol Brand names: Xopenex
Levalbuterol (Xopenex) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.262 per mL (Levalbuterol 0.31 mg/3 mL solution) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the levalbuterol FDA label on DailyMed (effective December 10, 2025, Ritedose Pharmaceuticals, LLC); the NDA 20837 record on Drugs@FDA; every levalbuterol label on DailyMed.
Highlights of the record
FDA label of December 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLevalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Forms and strengths
- 0.31 mg/3ml
- 0.63 mg/3ml
- 1.25 mg/3ml
- 1.25 mg/.5ml
Solution; aerosol (metered); solution (concentrate).
On the market
- Earliest approval on file
- March 25, 1999 Xopenex, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first April 9, 2008; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 12 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.262 per mL Levalbuterol 0.31 mg/3 mL solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2015 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 6,865 through July 30, 2026
What is levalbuterol used for?
From the label: indications and usageLevalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution, USP is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
FDA pharmacologic class: beta2-Adrenergic Agonist.
Source: FDA drug label (Levalbuterol), Ritedose Pharmaceuticals, LLC, effective December 10, 2025 (SPL set d6998949-e1cb-4c86-a480-c0dfd9cb75b5), via openFDA; the full label on DailyMed
Is there a generic for levalbuterol (Xopenex)?
The FDA approved the first generic levalbuterol on April 9, 2008. 12 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists levalbuterol from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levalbuterol (Xopenex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.262 per mL (Levalbuterol 0.31 mg/3 mL solution), up 5% from $0.251 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Levalbuterol 0.63 mg/3 mL solution (generic)
- Xopenex hfa 45 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Levalbuterol 0.31 mg/3 mL solution | Generic | $0.262 per mL | n/a | +5% |
| Levalbuterol 0.63 mg/3 mL solution | Generic | $0.248 per mL | n/a | +0.9% |
| Levalbuterol 1.25 mg/3 mL solution | Generic | $0.273 per mL | n/a | +6% |
| Levalbuterol conc 1.25 mg/0.5 | Generic | $5.22 per unit | n/a | +26% |
| Levalbuterol tar hfa 45 mcg inhaler | Generic | $3.55 per gram | n/a | +7% |
| Xopenex hfa 45 mcg inhaler | Brand | $4.99 per gram | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has levalbuterol been recalled?
The FDA's Enforcement Report lists 3 recalls naming levalbuterol since 2015: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 24, 2015 | Class III | Cipla Limited | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levalbuterol label say about other medicines?
The levalbuterol label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | contraindications | CONTRAINDICATIONS Levalbuterol Inhalation Solution, USP is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. |
| Digoxin | drug interactions | Consider monitoring potassium levels. ( 7.3 ) Digoxin: May decrease serum digoxin levels. |
| Epinephrine | drug interactions | 02/2020 7.1 Short-Acting Bronchodilators Avoid concomitant use of other short-acting sympathomimetic bronchodilators or epinephrine in patients being treated with Levalbuterol Inhalation Solution, USP. |
Source: FDA drug label (Levalbuterol), Ritedose Pharmaceuticals, LLC, effective December 10, 2025 (SPL set d6998949-e1cb-4c86-a480-c0dfd9cb75b5), via openFDA; the full label on DailyMed
What do FAERS reports show for levalbuterol?
The FDA Adverse Event Reporting System holds 6,865 reports that list levalbuterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 466 are coded as a death and 1,970 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other beta-2 agonists
- the pharmacologic class, with prices and generics
- Levalbuterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other