Prescription medicine
Albuterol Brand names: Ventolin, Proair
Albuterol (Ventolin) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 40 generic labelers, and pharmacies paid $0.288 per albuterol sulfate 2 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the albuterol FDA label on DailyMed (effective April 30, 2026, Ritedose Pharmaceuticals, LLC); the NDA 18473 record on Drugs@FDA; every albuterol label on DailyMed.
Highlights of the record
FDA label of April 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAlbuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
Forms and strengths
- 2 mg
- 4 mg
- 0.63 mg/3ml
- 0.83 mg/ml
- 1.25 mg/3ml
- 2 mg/5ml
- 2.5 mg/3ml
- 2.5 mg/.5ml
Solution; aerosol (metered); tablet; inhalant; syrup.
On the market
- Earliest approval on file
- May 1, 1981 Ventolin, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 71 first January 30, 1989; 28 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 46 of which 40 under generic applications, 8 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.288 per tablet Albuterol sulfate 2 mg tablet
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 20 since 2011 1 Class I among all firms' recalls; latest March 17, 2026; 10 more by firms not listed as its makers
- FAERS reports
- 292,136 through July 30, 2026
What is albuterol used for?
From the label: indications and usageAlbuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
Conditions named in the indications of albuterol's FDA labels, with every medicine labeled for each:
From other albuterol labelsAsthma: INDICATIONS AND USAGE Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
FDA pharmacologic class: beta2-Adrenergic Agonist.
Source: FDA drug label (Albuterol Sulfate Inhalation Solution), Ritedose Pharmaceuticals, LLC, effective April 30, 2026 (SPL set d4c532be-1f41-60d3-e053-2995a90a98be), via openFDA; the full label on DailyMed
Is there a generic for albuterol (Ventolin)?
The FDA approved the first generic albuterol on January 30, 1989. 71 generic applications are approved; 28 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 albuterol from 40 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1981 earliest approval on file
- 1989 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 albuterol (Ventolin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.288 per Albuterol sulfate 2 mg tablet, down 38% from $0.461 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Albuterol sul 2.5 mg/3 mL solution (generic)
- Ventolin hfa 90 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Albuterol 2.5 mg/0.5 mL solution | Generic | $0.516 per unit | n/a | +16% |
| Albuterol hfa 90 mcg inhaler | Generic | $1.83 per gram | n/a | -12% |
| Albuterol sul 0.63 mg/3 mL solution | Generic | $0.223 per mL | n/a | -11% |
| Albuterol sul 1.25 mg/3 mL solution | Generic | $0.212 per mL | n/a | -8% |
| Albuterol sul 2.5 mg/3 mL solution | Generic | $0.0612 per mL | n/a | -0.4% |
| Albuterol sulf 2 mg/5 mL syrup | Generic | $0.0318 per mL | n/a | -4% |
| Albuterol sulfate 2 mg tablet | Generic | $0.288 per tablet | $8.64 | -38% |
| Albuterol sulfate 4 mg tablet | Generic | $0.404 per tablet | $12.13 | -8% |
| Proair respiclick 90 mcg inhlr | Brand | $67.18 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +3% |
| Ventolin hfa 90 mcg inhaler | Brand | $2.88 per gram | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is albuterol in shortage?
No albuterol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all resolved, the latest updated August 27, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Albuterol Sulfate, Solution, 2.5 mg/.5 mL (NDC 0487-9901-30) | Nephron Pharmaceuticals Corporation | Resolved | August 27, 2026 |
| Albuterol Sulfate, Solution, 2.5 mg/.5 mL (NDC 64980-642-03) | Rising Pharma Holdings, Inc. | Resolved | August 27, 2026 |
| Albuterol Sulfate, Solution, 2.5 mg/.5 mL (NDC 76204-027-01) | Ritedose Pharmaceuticals, LLC | Resolved | August 27, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has albuterol been recalled?
The FDA's Enforcement Report lists 30 recalls naming albuterol since 2011: 1 Class I (the most serious), 26 Class II, 3 Class III; 5 still ongoing. 10 of them are by firms that FDA's NDC Directory does not list as a maker of albuterol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 17, 2026 | Class II | Nephron SC, LLC | Labelling: Illegible label |
| July 24, 2025 | Class III | Cipla USA, Inc. | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month … |
| June 27, 2023 | Class I | Cipla USA, Inc. | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| September 16, 2020 | Class II | Perrigo Company PLC | Defective Delivery System: Sustained trend of failure to dispense complaints. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the albuterol label say about other medicines?
The albuterol label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 37 other medicines name albuterol. 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 |
|---|---|---|
| Digoxin | drug interactions | Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. |
| Epinephrine | drug interactions | Drug Interactions Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution. |
Other labels that name albuterol
Source: FDA drug label (Albuterol Sulfate Inhalation Solution), Ritedose Pharmaceuticals, LLC, effective April 30, 2026 (SPL set d4c532be-1f41-60d3-e053-2995a90a98be), via openFDA; the full label on DailyMed
What do FAERS reports show for albuterol?
The FDA Adverse Event Reporting System holds 292,136 reports that list albuterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,583 are coded as a death and 84,002 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 else is labeled for the same conditions as albuterol?
10 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as albuterol or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluticasone and salmeterol | Asthma | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Budesonide and formoterol | Asthma | 2 labelers | $17.26 per gram 160-4.5 | No current entry |
| Fluticasone and vilanterol | Asthma | none listed | $3.90 per unit 100-25 | No current entry |
| Formoterol and mometasone | Asthma | none listed | $25.22 per gram 100 mcg-5 mcg inhaler | No current entry |
| Budesonide and formoterol and glycopyrrolate | Asthma | none listed | $61.41 per gram 160-9-4.8 mcg | No current entry |
| Fluticasone and umeclidinium and vilanterol | Asthma | none listed | $11.12 per unit 100-62.5-25 | No current entry |
| Budesonide | Asthma | 13 labelers | $0.676 per mL 0.5 mg/2 mL suspension | No current entry |
| Beclomethasone | Asthma | 2 labelers | $20.57 per gram 40 mcg | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does albuterol compare with medicines for the same use?
7 side-by-side pages set albuterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to albuterol
- 10 medicines for the same use
- Other beta-2 agonists
- the pharmacologic class, with prices and generics
- Albuterol side effects
- the label's list beside FAERS reports
- Albuterol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other