Albuterol Sulfate Inhalation Solution, 0.5% 2.5 mg/.5mL

Albuterol Sulfate · SOLUTION · Ritedose Pharmaceuticals, LLC

2 Recalls on RecordCurrently in Shortage

Plain English

Albuterol Sulfate Inhalation Solution, 0.5% is a solution containing albuterol sulfate at 2.5 mg/.5mL, taken respiratory (inhalation). Manufactured by Ritedose Pharmaceuticals, LLC.

Key Facts

Brand Name: Albuterol Sulfate Inhalation Solution, 0.5%
Generic Name: Albuterol Sulfate
NDC Code (Product): 76204-027
Manufacturer: Ritedose Pharmaceuticals, LLC
Strength: 2.5 mg/.5mL
Dosage Form: SOLUTION
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: ANDA218386
Marketing Start: 03/24/2025

Recall History

2 Recalls on Record

Class II03/17/2026

Nephron SC, LLC

Labelling: Illegible label

OngoingVoluntary: Firm initiated

Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea12,415 reports

wrong technique in product usage process10,570 reports

no adverse event8,268 reports

device delivery system issue7,768 reports

drug dose omission by device7,505 reports

asthma6,628 reports

cough5,894 reports

drug ineffective5,031 reports

fatigue4,762 reports

product dose omission issue4,693 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & 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 ther…

Warnings

WARNINGS 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. 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. CARDIOVASCULAR EFFECTS Albuterol inhalation solution, like all other beta-adrenergic agonists, can produce a clinically …

Contraindications

CONTRAINDICATIONS Albuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

Drug Interactions

Drug Interactions Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution.

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: Percent Incidence of Adverse Reactions Reaction Percent Incidence (N=135) Central Nervous System Tremors 20 Dizziness 7 Nervousness 4 Headache 3 Insomnia 1 Gastrointestinal Nausea 4 Dyspepsia 1 Ear, nose and throat Nasal congestion 1 Pharyngitis <1 Cardiovascular Tachycardia 1 Hypertensions 1 Respiratory Bronchospasm 8 Cough 4 Bronchitis 4 Wheezing 1 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 arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have also been reported after the use of inhaled albuterol. To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is Albuterol Sulfate Inhalation Solution, 0.5% used for?

Albuterol Sulfate Inhalation Solution, 0.5% contains Albuterol Sulfate. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.

Is Albuterol Sulfate Inhalation Solution, 0.5% a controlled substance?

Albuterol Sulfate Inhalation Solution, 0.5% is not classified as a controlled substance by the DEA.

What is the generic name for Albuterol Sulfate Inhalation Solution, 0.5%?

The generic name for Albuterol Sulfate Inhalation Solution, 0.5% is Albuterol Sulfate. There are 12 other brand versions of Albuterol Sulfate.

What is the NDC code for Albuterol Sulfate Inhalation Solution, 0.5% 2.5 mg/.5mL?

The NDC (National Drug Code) for Albuterol Sulfate Inhalation Solution, 0.5% 2.5 mg/.5mL is 76204-027, listed by Ritedose Pharmaceuticals, LLC.

Product NDC

76204-027

Package NDC

76204-027-01

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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