Albuterol Sulfate 2.5 mg/.5mL Solution, 30 pouches
Other active recalls for Albuterol Sulfate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta2-Adrenergic Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
- What exactly does albuterol do, and when should I use it?
- That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
- The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Albuterol Sulfate — tap one for details:
Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII O40UQP6WCF
A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.527 | $15.81 / 30 vials |
| Medicaid paysCMS SDUD · 12 mo | $1.15 | $34.43 / 30 vials |
| Medicare drug plans payPart D · Q2 2026 | $0.6296 | $18.89 / 30 vials |
| Medicare Part B allowsASP · J7611 | $0.232 / J7611 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Albuterol Sulfate 2.5 mg/.5mL 62135-0829-84 | Chartwell | 30 pouches | $0.527 | AN | Availability likely | — |
| Albuterol Sulfate 2.5 mg/.5mLthis 64980-0642-03 | Rising | 30 pouches | $0.527 | AN | Availability likely | — |
| Albuterol Sulfate Inhalation Solution, 0.5% 2.5 mg/.5mL 76204-0027-01 | Ritedose | 30 pouches | $0.527 | AN | Availability likely | — |
| Albuterol Sulfate 2.5 mg/.5mL 00487-9901-02 | Nephron | 1 pouch | — | AN | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64980-0642-03 You're viewing this | 30 POUCH in 1 CARTON (64980-642-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE | 2025-04-30 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The usual dosage for adults and pediatric patients 12 years of age and older is 2.5 mg of albuterol (one unit-of-use vial) administered 3 to 4 times daily by nebulization. More frequent administration or higher doses are not recommended. To administer 2.5 mg of albuterol, dilute 0.5 mL of the 0.5% solution for inhalation to a total volume of 3 mL with sterile normal saline solution and administer by nebulization.
The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes. Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution when mixed with other drugs in a nebulizer have not been established. The use of albuterol inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm.
During treatment, most patients gain optimum benefit from regular use of the nebulizer solution. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy. The nebulizer should be cleaned in accordance with the manufacturer’s instructions.
Failure to do so could lead to bacterial contamination of the nebulizer and possible infection.
⛔ Contraindications ▾
CONTRAINDICATIONS Albuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.
⚠️ Warnings ▾
WARNINGS Paradoxical Bronchospasm: Albuterol inhalation solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol inhalation solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial.
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is therefore essential that the physician instruct the patient in the need for further evaluation if his/her asthma becomes worse. Cardiovascular Effects: Albuterol inhalation solution, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms.
Although such effects are uncommon after administration of albuterol inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown.
Therefore, albuterol inhalation solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol inhalation solution than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Use of Anti-Inflammatory Agents: The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.
Paradoxical Bronchospasm: Albuterol inhalation solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol inhalation solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial.
Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is therefore essential that the physician instruct the patient in the need for further evaluation if his/her asthma becomes worse.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The results of clinical trials with albuterol inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related: No clinically relevant laboratory abnormalities related to albuterol inhalation solution were determined in these studies. Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of albuterol inhalation solution.
Percent Incident of Adverse Reaction
🔄 Drug Interactions ▾
Drug Interactions: Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.
Beta-Blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol inhalation solution, 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, cardioselective beta blockers could be considered, although they should be administered with caution. Diuretics: The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-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. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
Digoxin: 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. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Teratogenic Effects Pregnancy Category C: Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous (sc) doses of 0.025, 0.25, and 2.5 mg/kg (approximately 1/100, 1/10, and 1.0 times, respectively, the maximum recommended daily inhalation dose for adults on a mg/m 2 basis), showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg.
Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg isoproterenol (positive control) subcutaneously (approximately 1.0 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a 50 mg/kg dose (approximately 80 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). There are no adequate and well-controlled studies in pregnant women.
Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies.
No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness of albuterol inhalation solution and solution for inhalation in children below the age of 12 years have not been established.
🆘 Overdosage ▾
OVERDOSAGE The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. In isolated cases in children 2 to 12 years of age, tachycardia with rates > 200 beats/min has been observed.
As with all sympathomimetic l medications, cardiac arrest and even death may be associated with abuse of albuterol inhalation solution. Treatment consists of discontinuation of albuterol inhalation solution together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.
There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol inhalation solution. The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 810 times the maximum recommended daily inhalation dose for adults on an mg/m 2 basis or approximately 300 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In mature rats, the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 365 times the maximum recommended daily inhalation dose for adults on an mg/m 2 basis or approximately 135 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis).
In small young rats, the sc median lethal dose is approximately 2000 mg/kg (approximately 1600 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis or approximately 600 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). The inhalational median lethal dose has not been determined in animals.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established (see WARNINGS ).
The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.
Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol- O-methyl transferase. Pharmacokinetics: Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus and expired air.
Most of the absorbed dose was recovered in the urine 24 hours after drug administration. Following a 3 mg dose of nebulized albuterol, the maximum albuterol plasma level at 0.5 hour was 2.1 ng/mL (range 1.4 to 3.2 ng/mL). There was a significant dose-related response in FEV 1 and peak flow rate.
It has been demonstrated that following oral administration of 4 mg of albuterol, the elimination half-life was 5 to 6 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Albuterol inhalation solution, USP 0.5%, is a clear, colorless to light yellow solution, and is supplied in plastic sterile unit-of-use vials of 0.5 mL each, supplied in individual foil pouches: NDC 64980-642-03: 30 vials, each in an individual pouch. Storage and Handling PROTECT FROM LIGHT. Store vials in pouch until time of use.
Store between 20 °C to 25°C (68°F - 77°F), excursions permitted to 15 °C to 30 °C (59°F - 86°F) [see USP Controlled Room Temperature]. Rx Only Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 For Customer Service, Call: 1-844-874-7464 IC 3028 Issued: 02/2025 Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
📦 Storage and Handling ▾
Storage and Handling PROTECT FROM LIGHT. Store vials in pouch until time of use. Store between 20 °C to 25°C (68°F - 77°F), excursions permitted to 15 °C to 30 °C (59°F - 86°F) [see USP Controlled Room Temperature]. Rx Only Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 For Customer Service, Call: 1-844-874-7464 IC 3028 Issued: 02/2025 Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
📋 Description ▾
DESCRIPTION Albuterol inhalation solution, USP 0.5% contains albuterol sulfate USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate has the chemical name α 1 -[( tert-Butylamino) methyl]-4-hydroxy- m-xylene-α,α′-diol sulfate (2:1) (salt) and the following chemical structure: The molecular weight of albuterol sulfate is 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 • H 2 SO 4 Albuterol sulfate USP is a white crystalline powder, soluble in water and slightly soluble in ethanol.
The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol inhalation solution, USP 0.5%, is in concentrated form. Dilute 0.5 mL of the solution to 3 mL with sterile normal saline solution prior to administration by nebulization (see DOSAGE AND ADMINISTRATION ).
Each 0.5 mL Unit-of-Use Vial Contains: ACTIVE: 2.5 mg of albuterol (equivalent to 3 mg of albuterol sulfate USP) in a sterile, aqueous solution; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol inhalation solution, USP contains no sulfiting agents or preservatives. It is supplied in 0.5 mL sterile unit-of-use Vials.
Albuterol inhalation solution, USP is a clear, colorless to light yellow solution. Structure
💬 Information for Patients ▾
Information for Patients: The action of albuterol inhalation solution may last up to 6 hours or longer. Albuterol inhalation solution should not be used more frequently than recommended. Do not increase the dose or frequency of albuterol inhalation solution without consulting your physician.
If you find that treatment with albuterol inhalation solution becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using albuterol inhalation solution, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor or nervousness.
If you are pregnant or nursing, contact your physician about use of albuterol inhalation solution. Effective and safe use of albuterol inhalation solution includes an understanding of the way that it should be administered. Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution when mixed with other drugs in a nebulizer have not been established.
See illustrated Patient's Instructions for Use .