Albuterol Sulfate .63 mg/3mL Solution
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
Where does this data come from?
🩺 Clinical
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 ye...
Read the full MedlinePlus article ↗- 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 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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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.
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?
Why might an inactive ingredient be missing?
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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.189 | $14.15 / 75 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2539 | $19.04 / 75 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7613 | $0.063 / J7613 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Albuterol .63 mg/3mL 00378-7057-52 | Mylan | 5 pouches | $0.189 | AN | Availability likely | — |
| Albuterol Sulfate .63 mg/3mLthis 50742-0392-25 | Ingenus | 5 pouches | $0.189 | AN | Availability likely | — |
| Albuterol Sulfate .63 mg/3mL 00487-0301-01 | Nephron | 30 pouches | $0.251 | AN | Availability likely | +33% |
| Albuterol Sulfate .63 mg/3mL 62135-0826-84 | Chartwell | 30 pouches | $0.251 | AN | Availability likely | +33% |
| Albuterol Sulfate Inhalation Solution .63 mg/3mL 76204-0010-01 | Ritedose | 30 pouches | $0.251 | AN | Availability likely | +33% |
| Albuterol Sulfate .63 mg/3mL 59651-0183-25 | Aurobindo | 25 pouches | — | AN | FDA listed | — |
| Albuterol Sulfate .63 mg/3mL 64980-0643-03 | Rising | 30 pouches | — | AN | FDA listed | — |
| Albuterol Sulfate .63 mg/3mL 81894-0105-25 | Luoxin | 5 pouches | — | 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
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50742-0392-25 You're viewing this | 5 POUCH in 1 CARTON (50742-392-25) / 5 VIAL in 1 POUCH (50742-392-05) / 3 mL in 1 VIAL | 2024-11-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended. To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization.
Adjust nebulizer flow rate to deliver albuterol sulfate inhalation solution over 5 to 15 minutes. The use of albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.
Patients 6 to 12 years of age with more severe asthma (baseline FEV 1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose. Albuterol sulfate inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.
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 drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate inhalation solution, when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of albuterol sulfate inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor.
The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established. Albuterol sulfate inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.
⛔ Contraindications ▾
CONTRAINDICATIONS Albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS Paradoxical Bronchospasm: As with other inhaled beta-adrenergic agonists, albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol sulfate inhalation solution should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.
Use of Anti-Inflammatory Agents: The use of beta-adrenergic 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). 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 sulfate inhalation solution than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids). 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 sulfate inhalation solution, like 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 for albuterol sulfate inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce 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 sulfate inhalation solution like all other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trial Experience: Adverse events reported in >1% of patients receiving albuterol sulfate inhalation solution and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table. Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Sulfate Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg Albuterol Sulfate Inhalation Solution (N=115) 0.63 mg Albuterol Sulfate Inhalation Solution (N=117) Placebo (N=117) Asthma Exacerbation 13 11.1
8.5Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4
1.7Gastroenteritis 0.9 3.4
0.9Cold Symptoms 0 3.4
1.7Flu Syndrome 2.6 2.6
1.7Lymphadenopathy 2.6 0.9
1.7Skin/Appendage Infection 1.7 0 0 Urticaria 1.7 0.9 0 Migraine 0.9 1.7 0 Chest Pain 0.9 1.7 0 Bronchitis 0.9 1.7
0.9Nausea 1.7 0.9
0.9There was one case of ST segment depression in the 1.25 mg albuterol sulfate inhalation solution treatment group. No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were seen in this study. Postmarketing Experience: Metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution.
Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure. To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🆘 Overdosage ▾
OVERDOSAGE The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as 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, insomnia, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate inhalation solution.
Treatment consists of discontinuation of albuterol sulfate 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 sulfate inhalation solution.
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of albuterol sulfate inhalation solution on a mg/m 2 basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 mg/kg and 2000 mg/kg, respectively (approximately 260 and 1200 times the maximum recommended daily inhalation dose of albuterol sulfate inhalation solution on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. 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, recent data indicate that 10% to 50% of the beta-receptors in the human heart may be beta 2 -receptors. The precise function of these receptors, however, is not yet established. 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 urine collected during the 24 hours after drug administration.
Following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. Following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). The pharmacokinetics of albuterol following administration of 0.63 mg or 1.25 mg albuterol sulfate inhalation solution by nebulization have not been determined in children 2 to 12 years old.
Animal Pharmacology/Toxicology: Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in whole brain. Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently.
The clinical significance of these findings is unknown. Clinical Trials: The safety and efficacy of albuterol sulfate inhalation solution was evaluated in a 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in 349 children 6 to 12 years of age with mild-to-moderate asthma (mean baseline FEV 1 60% to 70% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids.
Patients were randomized to receive albuterol sulfate inhalation solution 0.63 mg, albuterol sulfate inhalation solution 1.25 mg, or placebo three times a day administered via a Pari LC Plus™ nebulizer and a Pari PRONEB™ compressor. Racemic albuterol, delivered by a chlorofluorocarbon (CFC) metered dose inhaler (MDI) or nebulized, was used on an as-needed basis as the rescue medication. Efficacy, as measured by the mean percent change from baseline in the area under the 6-hour curve for FEV 1 , was demonstrated for both active treatment regimens (n=112 [1.25 mg group] and n=110 [0.63 mg group]) compared with placebo (n=110) on day 1 and day 28.
Figures 1 and 2 illustrate the mean percentage change from pre-dose FEV 1 on day 1 and day 28, respectively. The mean baseline FEV 1 for all patients was
1.49L.…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Albuterol Sulfate Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg/3 mL and 1.25 mg/3 mL, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate inhalation solution is available in a shelf carton containing multiple foil pouches.
Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 50742-392-25 5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL (potency expressed as albuterol) contains 1.5 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 50742-393-25 5 foil pouches, each containing 5 vials, total 25 vials per carton Rx only STORAGE Store between 2°C to 25°C (36°F to 77°F).
Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week.
Discard the vial if the solution is not colorless. Keep out of the reach of children. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in China Revised: 08/2024 LXK0042/01 logo3
📦 Storage and Handling ▾
STORAGE Store between 2°C to 25°C (36°F to 77°F). Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week. Discard the vial if the solution is not colorless. Keep out of the reach of children. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in China Revised: 08/2024 LXK0042/01 logo3
📋 Description ▾
DESCRIPTION Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY ). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows: 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 is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials.
Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to between 3.0 and 5.0 (see HOW SUPPLIED ). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization.
For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of
3.6L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION ). structure