Albuterol
Albuterol is a fast-acting bronchodilator (a medicine that opens the airways) used to treat or prevent bronchospasm in people with reversible obstructive airway disease, and to prevent exercise-induced bronchospasm with certain inhalers.
Built from the FDA-approved label, dated Apr 26, 2024 · How this page is built

⚡ Quick answers about Albuterol
What is albuterol used for?
Albuterol opens up your airways when the muscles around them tighten (bronchospasm), as in asthma. Inhalers and powders are also used before exercise to prevent exercise-induced bronchospasm.
Read the full answer →How do I use my albuterol inhaler?
It is breathed in through your mouth. The usual pattern for bronchospasm is a couple of puffs every 4 to 6 hours, and before exercise it is used 15 to 30 minutes ahead.
Read the full answer →What side effects should I expect?
The most common are throat irritation, cough, upper respiratory irritation, viral respiratory infections and muscle or bone aches. These are usually manageable.
Read the full answer →When should I worry or get help?
Get help right away if your breathing gets worse after a dose, or if you have hives, swelling of the face or throat, or chest pain or a racing heartbeat.
Read the full answer →🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 103 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →📖 Albuterol: Patient Information Guide
A plain-language walkthrough of Albuterol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Albuterol is used for
▾
Albuterol relieves or prevents bronchospasm (tightening of the airway muscles) in reversible obstructive airway disease. Approved uses and ages vary by product.
- Treatment or prevention of bronchospasm in ages 4 and older: albuterol inhalers and inhalation powders, including ProAir Digihaler, ProAir RespiClick and Ventolin HFA.
- Prevention of exercise-induced bronchospasm in ages 4 and older: the same inhalers and inhalation powders.
- Relief of bronchospasm in ages 12 and older with acute attacks: albuterol inhalation solution (including the 0.5% strength) for nebulizers.
- Relief of bronchospasm in children 2 to 12 with asthma: albuterol inhalation solution in unit-dose vials.
- Relief of bronchospasm in adults and children 2 and older: albuterol sulfate syrup (by mouth).
- Relief of bronchospasm in adults and children 6 and older: albuterol tablets.
How Albuterol works
▾
Albuterol is a beta-2 agonist. It attaches to beta-2 receptors on the muscles around your airways. This triggers a chain of steps inside the muscle cells that lets them relax. The airways open, from the windpipe down to the smallest tubes.
It also reduces the release of irritating substances from mast cells in the airways. The heart has some beta-2 receptors too, so albuterol can affect heart rate and blood pressure in some people.
How Albuterol is taken (dosage)
▾
How albuterol is taken depends on the product, so follow your own label and prescriber.
- Inhalers and powders: breathed in through the mouth, usually every 4 to 6 hours for bronchospasm, or 15 to 30 minutes before exercise to prevent exercise-induced bronchospasm.
- Nebulizer solution: unit-dose vials are given through a nebulizer over about 5 to 15 minutes.
- Tablets and syrup: taken by mouth.
- Do not take more than directed.
Dosing details from the FDA-approved label
From the Albuterol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours by oral inhalation. In some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise by oral inhalation. ( 2.2 ) ProAir Digihaler does not require priming. ( 2.3 ) Do not use with a spacer or volume holding chamber. ( 2.3 ) Keep the inhaler clean and dry at all times. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water. ( 2.3 ) Discard 13 months after opening the foil pouch, when the dose counter displays 0, or after the expiration date on the product, whichever comes first. ( 2.3 ) ProAir Digihaler contains a built-in electronic module which detects, records, and stores data on inhaler events for transmission to the mobile App. Use of the App is not required for administration of medication to the patient. ( 2.3 ) 2.1 Recommended Dosage for Bronchospasm The recommended dosage is 2 inhalations every 4 to 6 hours by oral inhalation. More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient. 2.2 Recommended Dosage for Exercise-Induced Bronchospasm The recommended dosage is 2 inhalations 15 to 30 minutes before exercise by oral inhalation. 2.3 Administration and Maintenance Information Administer ProAir Digihaler by oral inhalation only. ProAir Digihaler inhaler does not require priming. Do not use ProAir Digihaler with a spacer or volume holding chamber. Keep the inhaler clean and dry at all times. Never wash or put any part of your inhaler in water. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. 2.4 Dose Counter ProAir Digihaler inhaler has a dose counter attached to the actuator. When the patient receives the inhaler: For the 200 dose canister, the number 200 will be displayed. For the 30 dose canister, the number 30 will be displayed. The dose counter will count down each time the inhaler is actuated.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Albuterol side effects in detail
▾
Common side effects
- Throat irritation
- Viral respiratory infections
- Upper respiratory inflammation
- Cough
- Musculoskeletal pain
When to get medical help
- Get help right away if breathing gets worse right after a dose (paradoxical bronchospasm). This can be life threatening, so stop the medicine.
- Call your doctor if you need more doses than usual. This can mean your asthma is getting worse.
- Get emergency help for signs of a severe allergic reaction, such as hives, swelling of the face, lips or throat, rash, or trouble breathing.
- Tell your doctor about fast or pounding heartbeat, chest pain, or big changes in blood pressure.
- Do not use more than recommended. Deaths have been reported with excessive use of inhaled drugs like this in people with asthma.
- Low potassium (hypokalemia) and changes in blood sugar can occur.
The most common side effects reported with albuterol HFA inhaler in trials were:
- Throat irritation
- Viral respiratory infections
- Upper respiratory inflammation
- Cough
- Musculoskeletal pain
Get help right away for worsening breathing after a dose, signs of a serious allergic reaction, or heart symptoms such as chest pain or a racing heartbeat.
Albuterol warnings and precautions
▾
- Paradoxical bronchospasm: airways may tighten after a dose, which can be life threatening. Stop the medicine and seek help.
- Worsening asthma: needing more doses than usual can mean asthma is getting worse and needs re-evaluation.
- Not a replacement for anti-inflammatory medicine: albuterol alone may not control asthma, and a corticosteroid may be needed.
- Heart effects: pulse, blood pressure and ECG changes can occur. Use caution with heart disease, irregular heartbeat or high blood pressure.
- Excessive use: deaths have been reported with overuse. Do not exceed the recommended dose.
- Allergic reactions: hives, swelling and anaphylaxis (a severe allergic reaction) can occur. ProAir Digihaler contains lactose, which may contain trace milk proteins.
- Potassium and blood sugar: low potassium and blood sugar changes can occur.
Albuterol interactions: what it interacts with
▾
Tell your pharmacist or doctor about all your medicines. Key ones to watch:
- Other short-acting airway-opening or adrenergic drugs: can add to the effects and the heart risks.
- Beta-blockers: can block albuterol's effect and cause severe bronchospasm in people with asthma.
- Non-potassium-sparing water pills (loop or thiazide): can worsen low potassium or ECG changes.
- Digoxin: albuterol may lower digoxin levels, so levels may be checked.
- MAO inhibitors and tricyclic antidepressants: can boost albuterol's effect on the heart and blood vessels.
Interactions listed in the FDA-approved label
From the Albuterol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Read the label’s full interactions text
7 DRUG INTERACTIONS Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. ( 7 ) Beta-blockers: May decrease effectiveness of ProAir Digihaler and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ( 7.1) Diuretics, or non-potassium sparing diuretics: May potentiate hypokalemia or ECG changes. Consider monitoring potassium levels. ( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.3 ) Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. ( 7.4 ) 7.1 Beta-Blockers Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic-blocking agents in patients with asthma. In this setting, consider cardioselective beta-blockers, although they should be administered with caution. 7.2 Diuretics The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Albuterol
▾
- Do not use ProAir Digihaler if you are allergic to albuterol or have a severe milk protein allergy.
- Check first if you have heart disease, irregular heartbeat, high blood pressure, seizures, an overactive thyroid or diabetes.
- People with kidney problems clear albuterol more slowly, so caution is advised with high doses.
- Pregnancy: use during labor should be limited to cases where the benefit clearly outweighs the risk. Talk with your doctor if you are pregnant.
- Breastfeeding: albuterol levels after inhaled doses are low, but discuss it with your doctor.
- Children: inhaler products are for ages 4 and older, tablets 6 and older, syrup 2 and older, and nebulizer solutions vary by product.
- Older adults: doses are usually started low.
Albuterol overdose: if you take too much
▾
Too much albuterol can cause chest pain, high blood pressure, a very fast heartbeat, nervousness, headache, tremor, dry mouth, nausea, dizziness and trouble sleeping. Seizures, low blood pressure, irregular heartbeat and low potassium can also occur. Cardiac arrest and death have been linked to abuse. Treatment is to stop the medicine and treat symptoms, so get emergency help right away.
Pharmacodynamics: what Albuterol does in the body
▾
In a study of an albuterol powder inhaler, a single dose opened the airways significantly better than placebo and about as well as ProAir HFA. At high cumulative doses, it caused changes in blood sugar, potassium, heart rate and blood pressure. It also prolonged the QT interval (a heart rhythm measure on an ECG), as other beta-2 agonists do.
Pharmacokinetics: how your body processes Albuterol
▾
After inhalation, albuterol is absorbed quickly, with peak blood levels about half an hour later. Its effective half-life is about 5 hours. It is broken down mainly by an enzyme called sulfotransferase. Most of it leaves through the kidneys (80% to 100%). With kidney impairment, clearance dropped by about 67%.
How to store Albuterol
▾
store near heat or open flame. Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) . Store the inhaler with the mouthpiece down.
📄 Written from Albuterol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Albuterol
32 supplements and herbal products have documented interactions with Albuterol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 22
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Albuterol has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 1
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Albuterol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Albuterol — the kind of thing our pharmacy team would talk through with you at the counter.
What is albuterol used for?
▾
How do I use my albuterol inhaler?
▾
What side effects should I expect?
▾
When should I worry or get help?
▾
Can I take it with my other medicines?
▾
Is it safe during pregnancy?
▾
Is Albuterol available over the counter?
▾
When was Albuterol first available?
▾
Who makes Albuterol?
▾
💬 Answers drafted from Albuterol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Albuterol on HelloPharmacist
💊 Albuterol forms and strengths (how it comes)
Albuterol is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Inhaler
How this form is used
- Albuterol Sulfate HFA and Albuterol Sulfate Inhalation Aerosol are used to treat or prevent bronchospasm in people 4 years and older with reversible obstructive airway disease.
- Albuterol Sulfate HFA and Albuterol Sulfate Inhalation Aerosol are also used to prevent exercise-induced bronchospasm in people 4 years and older.
- Albuterol Sulfate HFA and Albuterol Sulfate Inhalation Aerosol are for oral inhalation only, generally every 4 to 6 hours for bronchospasm.
- Albuterol Sulfate HFA and Albuterol Sulfate Inhalation Aerosol are used 15 to 30 minutes before exercise to prevent exercise-induced bronchospasm.
- Albuterol Sulfate HFA and Albuterol Sulfate Inhalation Aerosol need priming before first use or after a period of not being used, with sprays released into the air away from the face.
- Albuterol Sulfate HFA and Albuterol Sulfate Inhalation Aerosol should have the actuator washed with warm water at least once a week and air dried completely.
Inhalation solution (nebulizer)
How this form is used
- Albuterol Sulfate Inhalation Solution, 0.5% is used for relief of bronchospasm in people 12 years and older with reversible obstructive airway disease and acute attacks of bronchospasm.
- Albuterol Sulfate Inhalation Solution (unit-dose vials) is used for relief of bronchospasm in children 2 to 12 years of age with asthma.
- Albuterol Sulfate Inhalation Solution unit-dose vials are given by nebulization, using the whole vial, over about 5 to 15 minutes.
- Albuterol Sulfate Inhalation Solution in children 2 to 12 is generally used 3 or 4 times daily as needed, and more frequent use is not recommended.
Tablet
How this form is used
- Albuterol tablets are used for relief of bronchospasm in adults and children 6 years and older with reversible obstructive airway disease.
- Albuterol tablets are taken by mouth. Follow your prescriber's directions and the product label.
Oral solution
How this form is used
- Albuterol Sulfate Syrup is used for relief of bronchospasm in adults and children 2 years and older with reversible obstructive airway disease.
Inhalation powder
How this form is used
- ProAir Digihaler is used to treat or prevent bronchospasm in people 4 years and older with reversible obstructive airway disease.
- ProAir RespiClick is used to treat or prevent bronchospasm and to prevent exercise-induced bronchospasm in people 4 years and older.
- ProAir Digihaler and ProAir RespiClick are for oral inhalation only and do not require priming.
- Do not use ProAir Digihaler or ProAir RespiClick with a spacer or volume holding chamber.
- Keep ProAir Digihaler and ProAir RespiClick clean and dry. Wipe the mouthpiece with a dry cloth if needed, and never put any part in water.
- ProAir Digihaler and ProAir RespiClick should be discarded 13 months after opening the foil pouch, when the dose counter shows 0, or after the expiration date.
🖼️ What Albuterol products look like
Images from the FDA-filed labels on DailyMed — packaging and, where the labeler provides one, the tablet or capsule itself. Appearance varies by manufacturer; your pharmacy's product may differ.
Source: DailyMed label media (National Library of Medicine).
📊 Albuterol on the U.S. market: products, makers and brands
How Albuterol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
77 companies list 342 Albuterol product records with the FDA, mostly as inhaler, inhalation solution (nebulizer), tablet; the earliest marketing or approval year on record is 1986. Brand names on the directory include VoSpire ER, Proventil Syrup, Proventil Tablets and 13 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (21) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Albuterol is used (Medicaid data)
A general measure of how commonly Albuterol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Albuterol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Albuterol prescribed? Of the 1,600 medications we measure, Albuterol ranks #1 by Medicaid prescriptions — more than 100% of them.
Utilization by Albuterol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler Most dispensed
Summed across the 2 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2123076
NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
Summed across the 4 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2123072
albuterol 0.83 MG/ML Inhalation Solution
Summed across the 19 of 80 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 630208
NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
Summed across the 5 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2123111
albuterol 0.417 MG/ML Inhalation Solution
Summed across the 8 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351136
albuterol 0.21 MG/ML Inhalation Solution
Summed across the 6 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351137
200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1649560
albuterol 5 MG/ML Inhalation Solution
Summed across the 4 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 245314
albuterol 0.4 MG/ML Oral Solution
Summed across the 3 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 755497
NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 801092
albuterol 2 MG Oral Tablet
Summed across the 4 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197316
albuterol 4 MG Oral Tablet
Summed across the 3 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197318
Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2166796
Other Albuterol products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 65 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Albuterol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 63 of 352 listed Albuterol NDCs with Medicaid activity.
🔍 Compare Albuterol products
A representative set of FDA-listed product records for Albuterol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhalation powder | ||||
| 90 mcg | Respiratory (inhalation) | RPK Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Teva Respiratory, LLC × 5 listings | NDA | View NDC → |
| 💊Inhalation solution (nebulizer) | ||||
| 2.5 mg/3 mL | Respiratory (inhalation) | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| 5 mg/mL | Respiratory (inhalation) | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Respiratory (inhalation) | Akorn | ANDA | View NDC → |
| 2.5 mg/3 mL | Respiratory (inhalation) | American Health Packaging × 3 listings | ANDA | View NDC → |
| 2.5 mg/3 mL | Respiratory (inhalation) | Asclemed USA, Inc. × 2 listings | ANDA | View NDC → |
| 2.5 mg/3 mL | Respiratory (inhalation) | Asclemed Usa Inc. | ANDA | View NDC → |
| 0.63 mg/3 mL | Respiratory (inhalation) | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 0.83 mg/mL | Respiratory (inhalation) | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 1.25 mg/3 mL | Respiratory (inhalation) | Aurobindo Pharma Limited × 3 listings | ANDA | View NDC → |
| 2.5 mg/0.5 mL | Respiratory (inhalation) | Cardinal Health 107, LLC | ANDA | View NDC → |
| 2.5 mg/3 mL | Respiratory (inhalation) | Cardinal Health 107, LLC × 6 listings | ANDA | View NDC → |
| 0.63 mg/3 mL | Respiratory (inhalation) | Chartwell RX, LLC | ANDA | View NDC → |
| 💊Inhaler | ||||
| 90 mcg | Respiratory (inhalation) | A-S Medication Solutions × 7 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | A-S Medication Solutions × 7 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | A-S Medication Solutions × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 108 mcg | Respiratory (inhalation) | A-S Medication Solutions | NDA | Find on DailyMed ↗ |
| 108 mcg | Respiratory (inhalation) | A-S Medication Solutions | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Advanced Rx of Tennessee, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Advanced Rx Pharmacy of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Advanced Rx Pharmacy of Tennessee, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | American Health Packaging × 3 listings | ANDA | View NDC → |
| 90 mcg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Armstrong Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Asclemed USA, Inc. × 2 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Asclemed USA, Inc. × 2 listings | ANDA | View NDC → |
| 108 mcg | Respiratory (inhalation) | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Find on DailyMed ↗ |
| 90 mcg | Respiratory (inhalation) | Cipla USA Inc. × 4 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Civica Inc. | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Direct Rx | NDA | Find on DailyMed ↗ |
| 90 mcg | Respiratory (inhalation) | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 3 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Hawaii Repack, Inc. | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | HF Acquisition Co LLC, DBA HealthFirst × 2 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | HF Acquisition Co LLC, DBA HealthFirst × 4 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Lupin Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | NuCare Pharmaceuticals,Inc. × 8 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | NuCare Pharmaceuticals,Inc. × 4 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | NuCare Pharmaceuticals,Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 108 mcg | Respiratory (inhalation) | NuCare Pharmaceuticals,Inc. × 2 listings | NDA AUTHORIZED GENERIC | Find on DailyMed ↗ |
| 90 mcg | Respiratory (inhalation) | Padagis Israel Pharmaceuticals Ltd × 3 listings | ANDA | View NDC → |
| 108 mcg | Respiratory (inhalation) | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Find on DailyMed ↗ |
| 90 mcg | Respiratory (inhalation) | Prasco Laboratories × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals, Inc | NDA | Find on DailyMed ↗ |
| 90 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 108 mcg | Respiratory (inhalation) | Preferred Pharmaceuticals Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Proficient Rx LP × 4 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Proficient Rx LP × 5 listings | NDA | View NDC → |
| 108 mcg | Respiratory (inhalation) | Proficient Rx LP | NDA AUTHORIZED GENERIC | View NDC → |
| 108 mcg | Respiratory (inhalation) | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Remedyrepack Inc. × 9 listings | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Remedyrepack Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Remedyrepack Inc. × 4 listings | ANDA | View NDC → |
| 108 mcg | Respiratory (inhalation) | Remedyrepack Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | RPK Pharmaceuticals, Inc. × 2 listings | NDA | Find on DailyMed ↗ |
| 90 mcg | Respiratory (inhalation) | RPK Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | RPK Pharmaceuticals, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 108 mcg | Respiratory (inhalation) | RPK Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 108 mcg | Respiratory (inhalation) | Sandoz × 2 listings | NDA | View NDC → |
| 108 mcg | Respiratory (inhalation) | Sandoz Inc × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Sportpharm LLC × 3 listings | ANDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 90 mcg | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | NDA | View NDC → |
| 90 mcg | Respiratory (inhalation) | Teva Respiratory, LLC × 5 listings | NDA | View NDC → |
| 💊Oral solution | ||||
| 0.63 mg/3 mL | Intrabronchial | Actavis Pharma, Inc. | ANDA | View NDC → |
| 1.25 mg/3 mL | Intrabronchial | Actavis Pharma, Inc. | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 15 kg/15 kg | — | AstraZeneca AB | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Cambrex Profarmaco Milano Srl | BULK INGREDIENT | View NDC → |
| 1 kg | — | Catalent Micron Technologies, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 25 kg/25 kg | — | Cipla Ltd. | BULK INGREDIENT | View NDC → |
| 30 kg/30 kg | — | Cipla Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | FDC Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Kindeva Drug Delivery Limited | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Lusochimica SPA × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Melody Healthcare Pvt. Ltd. × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Neuland Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America dba PCCA | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 100 kg/100 kg | — | SICOR Societa' Italiana Corticosteroidi s.r.l. × 4 listings | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Supriya Lifescience Limited | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Vamsi Labs Limited. | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
Showing 200 of 342 products — FDA National Drug Code Directory. See every product, package size and price: browse all 342 Albuterol NDCs →
📈 Albuterol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Albuterol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Albuterol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Albuterol FDA approval history
How Albuterol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Albuterol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
No recall of any Albuterol product is on record in the FDA enforcement database.
✅No recalls found for Albuterol in the FDA databaseSource: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 435 9 dose forms · 25 strengths
-
Dose form (SCDF) Dry Powder Inhaler RxCUI 1649559In current FDA listingsClinical drug / strength (SCD) Sensor 200 ACTUAT albuterol 0.09 MG/ACTUATRxCUI 2166796200 ACTUAT albuterol 0.09 MG/ACTUATRxCUI 1649560 -
Dose form (SCDF) Extended Release Oral Capsule RxCUI 379496No current FDA listingClinical drug / strength (SCD) 4 MGRxCUI 1537418 MGRxCUI 153742 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 370543No current FDA listingClinical drug / strength (SCD) 12 HR albuterol 4 MGRxCUI 35914412 HR albuterol 8 MGRxCUI 359145 -
Dose form (SCDF) Inhalation Powder RxCUI 2108233In current FDA listingsClinical drug / strength (SCD) 0.1 MGRxCUI 2522980.2 MGRxCUI 3077790.4 MGRxCUI 104514 -
Dose form (SCDF) Inhalation Solution RxCUI 2108226In current FDA listingsClinical drug / strength (SCD) 0.21 MG/MLRxCUI 3511370.417 MG/MLRxCUI 3511360.83 MG/MLRxCUI 6302082 MG/MLRxCUI 2478405 MG/MLRxCUI 245314 -
Dose form (SCDF) Injectable Solution RxCUI 370790No current FDA listingClinical drug / strength (SCD) 0.1 MG/MLRxCUI 3869980.5 MG/MLRxCUI 1999241 MG/MLRxCUI 248066 -
Dose form (SCDF) Metered Dose Inhaler RxCUI 745678In current FDA listingsClinical drug / strength (SCD) NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUATRxCUI 2123111NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUATRxCUI 2123076NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUATRxCUI 801092NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUATRxCUI 2123072 -
Dose form (SCDF) Oral Solution RxCUI 544499In current FDA listingsClinical drug / strength (SCD) 0.4 MG/MLRxCUI 755497 -
Dose form (SCDF) Oral Tablet RxCUI 370542In current FDA listings
Look up RxCUI 435 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Albuterol supply and shortage status
Whether Albuterol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Albuterol brand names
Albuterol is sold under 16 brand names in the FDA directory — VoSpire ER, Proventil Syrup, Proventil Tablets, Ventolin Syrup and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Albuterol: manufacturers and labelers
40 companies list Albuterol products with the FDA. By number of product records, the largest are A-S Medication Solutions, NuCare Pharmaceuticals,Inc., Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 16 more on the FDA NDC directory.
Albuterol drug class (RxNorm)
Albuterol belongs to the beta2-Adrenergic Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Albuterol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 103 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.