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ALBUTEROL SULFATE 2.5 mg/3mL Solution — NDC 51662-1499-1 (Billing 51662-1499-01)

by HF Acquisition Co LLC, DBA HealthFirst · 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

This is a package of ALBUTEROL SULFATE 2.5 mg/3mL Solution from HF Acquisition Co LLC, DBA HealthFirst, marketed since Jan 2020 and currently FDA-listed. It is this product's only package size.

NDC 51662-1499-01
🏷️ FDA NDC (as labeled) 51662-1499-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Albuterol Sulfate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jul 24, 2025 — Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. (Cipla USA, Inc.) · FDA recall D-0593-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1499-1
Product NDC 51662-1499
11-digit billing NDC 51662149901
RxCUI 630208
UNII 021SEF3731
UPC 0304879501003
Application # ANDA074880
SPL Set ID 9d4ef83f-8ca0-811e-e053-2995a90a6d0d
Established class (EPC) beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-29
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance ALBUTEROL SULFATE
TE code (Orange Book) AN · RLD · RS
Quick answers
  • RxCUI (RxNorm): 630208
Why two NDCs? The FDA registers this code as 51662-1499-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51662-1499-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor agonists
How it works Adrenergic beta2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • 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 br...
  • 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. Some inhale...
  • The most common are throat irritation, cough, upper respiratory irritation, viral respiratory infections and muscle or bone aches. These are usually manageable. Call me or your doc...
  • 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. Also call your doctor if y...
📖 Read our full Albuterol guide →
2
Nutrient depletion considerations

Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Albuterol Sulfate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1002 $1.50 / 15 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1499-01 You're viewing this Main listing 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 2020-01-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuterol Sulfate 2.5 mg/3mL 00378-8270-52 Mylan 1 pouch $0.060 AN Availability likely —
Albuterol Sulfate .83 mg/mL 47335-0703-49 Sun 5 pouches $0.060 AN Availability likely —
Albuterol Sulfate 2.5 mg/3mL 62135-0828-84 Chartwell 6 pouches $0.061 AN Availability likely —
Albuterol Sulfate 2.5 mg/3mL 00487-9501-01 Nephron 30 pouches $0.061 AN Availability likely —
Albuterol Sulfate 2.5 mg/3mL 60687-0395-83 American 30 pouches $0.061 AN Availability likely —
Albuterol Sulfate 2.5 mg/3mL 76204-0200-01 Ritedose 30 pouches $0.061 AN Availability likely —
Albuterol Sulfate 2.5 mg/3mL 50090-0516-00 A-S 1 pouch — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 50090-6560-00 A-S 25 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mLthis 51662-1499-01 HF 5 vials — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 55154-2132-05 Cardinal 5 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 55154-4410-05 Cardinal 5 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 63187-0204-25 Proficient 1 pouch — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 64980-0641-02 Rising 1 pouch — AN FDA listed —
Albuterol Sulfate .83 mg/mL 65862-0858-03 Aurobindo 30 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 68071-3780-02 NuCare 1 pouch — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 68071-4543-06 NuCare 3 ml — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 68071-4754-02 NuCare 3 ml — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 68788-8399-02 Preferred 25 ampules — AN FDA listed —
Albuterol Sulfate .83 mg/mL 68788-8492-02 Preferred 5 pouches — AN FDA listed —
Albuterol Sulfate .83 mg/mL 70518-3560-00 REMEDYREPACK 12 pouches — AN Discontinued —
Albuterol Sulfate .83 mg/mL 70518-4490-00 REMEDYREPACK 5 pouches — AN FDA listed —
Albuterol Sulfate .83 mg/mL 71205-0641-25 Proficient 5 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 71872-7054-01 Medical 1 ampule — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 76420-0087-03 Asclemed 1 vial — AN FDA listed —
Albuterol Sulfate .83 mg/mL 81894-0104-02 Luoxin 30 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 85766-0127-01 Sportpharm 30 pouches — AN FDA listed —
Albuterol Sulfate 2.5 mg/3mL 87063-0031-01 ASCLEMED 30 pouches — AN FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderNEPHRON CORP
FDA applicationANDA074880 (ANDA)
Labeler code51662
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio333 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

INDICATIONS & USAGE Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

⏱️ Dosage and Administration 192 words ▾

DOSAGE & ADMINISTRATION Adults and Children 2 to 12 Years of Age: The usual dosage for adults and for children weighing at least 15 kg is 2.5 mg of albuterol (one vial) administered three to four times daily by nebulization. Children weighing < 15 kg who require < 2.5 mg/dose (i.e., less than a full vial) should use albuterol inhalation solution, 0.5% instead of albuterol inhalation solution, 0.083%. More frequent administration or higher doses are not recommended.

To administer 2.5 mg of albuterol, administer the entire contents of one sterile unit-dose vial (3 mL of 0.083% inhalation solution) 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. 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. 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 that would require reassessment of therapy.

⛔ Contraindications 19 words ▾

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

⚠️ Warnings 115 words ▾

WARNINGS As with other inhaled beta-adrenergic agonists, albuterol sulfate inhalation solution can produce paradoxical bronchospasm, which can be life threatening. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. 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. In individual patients, any beta 2-adrenergic agonist, including albuterol solution for inhalation, may have a clinically significant cardiac effect. Immediate hypersensitivity reactions may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.

🤒 Adverse Reactions 212 words ▾

ADVERSE REACTIONS The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related: Central Nervous System: tremors (20%), dizziness (7%), nervousness (4%), headache (3%), insomnia (1%). Gastrointestinal: nausea (4%), dyspepsia (1%). Ear, Nose and Throat: pharyngitis (<1%), nasal congestion (1%).

Cardiovascular: tachycardia (1%), hypertension (1%). Respiratory: bronchospasm (8%), cough (4%), bronchitis (4%), wheezing (1%). No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were determined in these studies.

In comparing the adverse reactions reported for patients treated with albuterol sulfate inhalation solution with those of patients treated with isoproterenol during clinical trials of three months, the following moderate to severe reactions, as judged by the investigators, were reported. This table does not include mild reactions. *The finding of no arrhythmias and no palpitations after albuterol administration in the clinical study should not be interpreted as indicating that these adverse effects cannot occur after the administration of inhaled albuterol. +In most cases of bronchospasm, this term was generally used to describe exacerbations in the underlying pulmonary disease.

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, arrhythmias (including atrial fibrillations, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate inhalation solution. ADVERSE

🆘 Overdosage 86 words ▾

OVERDOSAGE Manifestations of overdosage may include seizures, anginal pain, hypertension, hypokalemia, tachycardia with rates up to 200 beats/min, and exaggeration of the pharmacological effects listed in ADVERSE REACTIONS . In isolated cases in children 2 to 12 years of age, tachycardia with rates > 200 beats/min has been observed. The oral LD 50 in rats and mice was greater than 2,000 mg/kg.

The inhalation LD 50 could not be determined. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol inhalation solution.

🧬 Clinical Pharmacology ~3 min read ▾

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, 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. 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. Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either IPPB (intermittent positive-pressure breathing) 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 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). There was a significant dose-related response in FEV 1 (forced expiratory volume in one second) and peak flow rate.

It has been demonstrated that following oral administration of 4 mg of albuterol, the elimination half-life was five to six hours. Animal studies show that albuterol does not pass the blood-brain barrier. Recent studies in laboratory animals (minipigs, rodents, and dogs) recorded the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines were administered concurrently.

The significance of these findings when applied to humans is currently unknown. In controlled clinical trials, most patients exhibited an onset of improvement in pulmonary function within 5 minutes as determined by FEV 1. FEV 1 measurements also showed that the maximum average improvement in pulmonary function usually occurred at approximately 1 hour following inhalation of 2.5 mg of albuterol by compressor-nebulizer and remained close to peak for 2 hours.

Clinically significant improvement in pulmonary function (defined as maintenance of a 15% or more increase in FEV 1 over baseline values) continued for 3 to 4 hours in most patients and in some patients continued up to 6 hours. In repetitive dose studies, continued effectiveness was demonstrated throughout the three-month period of treatment in some patients. Published reports of trials in asthmatic children aged 3 years or older have demonstrated significant improvement in either FEV 1 or PEFR within 2 to 20 minutes following a single dose of albuterol inhalation solution.

An increase of 15% or more in baseline FEV 1 has been observed in children aged 5 to 11 years up to 6 hours after treatment with doses of 0.10 mg/kg or higher of albuterol inhalation solution. Single doses of 3, 4, or 10 mg resulted in improvement in baseline PEFR that was comparable in extent and duration to a 2 mg dose, but doses above 3 mg were associated with heart rate increases of more… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 131 words ▾

HOW SUPPLIED ALBUTEROL SULFATE INHALATION SOLUTION is supplied in the following dosage forms. NDC 51662-1499-1 ALBUTEROL SULFATE INHALATION SOLUTION 0.083% 2.5mg/3mL 5x3mL UNIT-DOSE VIALS HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Albuterol Sulfate Inhalation Solution, 0.083% is contained in plastic, sterile, unit dose vials of 3 mL each, supplied in foil pouches: NDC 0487-9501-25: carton of 25 vials NDC 0487-9501-03: carton of 30 vials NDC 0487-9501-60: carton of 60 vials NDC 0487-9501-01: 30 vials, each in an individual foil pouch.

Storage and Handling PROTECT FROM LIGHT. Store vials in pouch until time of use. Store between 2° and 25° C (36° and 77° F).

Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313

📋 Description 160 words ▾

DESCRIPTION Albuterol sulfate inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α′-diol sulfate (2:1) (salt) and the following structural formula: Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C 13H 21NO 3) 2 •H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol.

The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each mL of albuterol sulfate inhalation solution (0.083%) contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5.

Albuterol sulfate inhalation solution (0.083%) contains no sulfiting agents. Albuterol sulfate inhalation solution is a clear, colorless solution. STRUCTURE

💬 Patient Medication Information 6 words ▾

PATIENT PACKAGE INSERT PATIENT PACKAGE INSERT

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Albuterol, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension, in patients with convulsive disorders, hyperthyroidism or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. As with other beta-agonists, inhaled and intravenous albuterol may produce a significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

The decrease is usually transient, not requiring supplementation. Repeated dosing with 0.15 mg/kg of albuterol inhalation solution in children aged 5 to 17 years who were initially normokalemic has been associated with an asymptomatic decline of 20% to 25% in serum potassium levels. Information for Patients The action of albuterol sulfate inhalation solution may last up to six hours, and therefore it should not be used more frequently than recommended.

Do not increase the dose or frequency of medication without medical consultation. If symptoms get worse, medical consultation should be sought promptly. While taking albuterol sulfate inhalation solution, other anti-asthma medicines should not be used unless prescribed.

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 . Drug Interactions Other sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol.

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of albuterol on the vascular system may be potentiated. Beta-receptor blocking agents and albuterol inhibit the effect of each other. Carcinogenesis, Mutagenesis, Impairment of Fertility Albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium in a 2-year study in the rat, at oral doses of 2, 10, and 50 mg/kg, corresponding to 10, 50, and 250 times, respectively, the maximum nebulization dose for a 50 kg human.

In another study, this effect was blocked by the coadministration of propranolol. The relevance of these findings to humans is not known. An 18-month study in mice and a lifetime study in hamsters revealed no evidence of tumorigenicity.

Studies with albuterol revealed no evidence of mutagenesis. Reproduction studies in rats revealed no evidence of impaired fertility. Pregnancy Teratogenic Effects Pregnancy Category C Albuterol has been shown to be teratogenic in mice when given subcutaneously in doses corresponding to 1.25 times the human nebulization dose (based on a 50 kg human).

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. A reproduction study in CD-1 mice with albuterol (0.025, 0.25, and 2.5 mg/kg subcutaneously, corresponding to 0.125, 1.25, and 12.5 times the maximum human nebulization dose, respectively) 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.

None were observed at 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses treated with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses at 50 mg/kg, corresponding to 250 times the maximum nebulization dose for a 50-kg human.

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL LABEL

PRINCIPAL DISPLAY PANEL - 5 X 3 mLSLEEVE POUCH LABELING SLEEVE LABELING

PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING SERIALIZED LABELING P1 SERIALIZED LABELING P2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Albuterol Sulfate — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Albuterol Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.45M
Claims incl. refills
74.8K
Beneficiaries
44.4K
Spend / beneficiary
$55.14
Spend / claim
$32.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51662-1498-01 · HF 51662-1503-01 · HF →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.