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Albuterol Sulfate 1.25 mg/3mL Solution — NDC 64980-0644-02 package photo
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Albuterol Sulfate 1.25 mg/3mL Solution — NDC 64980-644-02 (Billing 64980-0644-02)

by Rising Pharma Holdings, Inc · 25 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

This is a package of Albuterol Sulfate 1.25 mg/3mL Solution from Rising Pharma Holdings, Inc, marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 64980-0644-02
🏷️ FDA NDC (as labeled) 64980-644-02 billing pads the product 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 Aug 13, 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

NDC database record

One package, one record: these facts belong to NDC 64980-644-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64980 labeler · 644 product · 02 package
Package marketed since
Apr 30, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0364980644020, 0364980643030
FDA record last changed
Aug 13, 2026
⚠️
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) 64980-644-02
Product NDC 64980-644
11-digit billing NDC 64980064402
RxCUI 351136, 351137
UNII 021SEF3731
UPC 0364980644020, 0364980643030
Application # ANDA076355
SPL Set ID 32474c0e-af35-69d1-e063-6394a90a53c6
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 2025-04-14
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance ALBUTEROL SULFATE
TE code (Orange Book) AN · RLD · RS
Quick answers
  • RxCUI (RxNorm): 351136
Why two NDCs? The FDA registers this code as 64980-644-02 — a 5-3-2 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 product segment → 64980-0644-02. 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
64980-0644-02 You're viewing this Main listing 25 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 2025-04-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuterol 1.25 mg/3mL 00378-7058-52 Mylan 5 pouches $0.198 AN Availability likely —
Albuterol Sulfate 1.25 mg/3mL 50742-0393-25 Ingenus 5 pouches $0.198 AN Availability likely —
Albuterol Sulfate 1.25 mg/3mL 62135-0827-84 Chartwell 30 pouches $0.220 AN Availability likely —
Albuterol Sulfate 1.25 mg/3mL 00487-9904-01 Nephron 30 pouches $0.226 AN Availability likely —
Albuterol Sulfate Inhalation Solution 1.25 mg/3mL 76204-0011-01 Ritedose 30 pouches $0.226 AN Availability likely —
Albuterol Sulfate 1.25 mg/3mL 59651-0184-25 Aurobindo 25 pouches — AN FDA listed —
Albuterol Sulfate 1.25 mg/3mLthis 64980-0644-02 Rising 25 pouches — AN FDA listed —
Albuterol Sulfate 1.25 mg/3mL 81894-0106-25 Luoxin 5 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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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

LabelerRising Pharma Holdings, Inc
Application holderNEPHRON PHARMACEUTICALS CORP
FDA applicationANDA076355 (ANDA)
Labeler code64980
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio5 products on file

More NDCs from Rising Pharma Holdings, Inc labeler code 64980

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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Albuterol 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 ~2 min read ▾

DOSAGE AND ADMINISTRATION The usual starting dosage for patients 2 to 12 years of age is 1.25 mg (0.042%) or 0.63 mg (0.021%) of albuterol 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 0.042% [1.25 mg] or 3 mL of 0.021% [0.63 mg] inhalation solution) by nebulization.

Adjust nebulizer flow rate to deliver albuterol inhalation solution over 5 to 15 minutes. The use of albuterol 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 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 inhalation solution, when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of albuterol 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 inhalation solution when administered with other nebulizer systems have not been established.

Albuterol 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 18 words ▾

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

⚠️ Warnings ~1 min read ▾

WARNINGS Paradoxical Bronchospasm: As with other inhaled beta-adrenergic agonists, 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 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 inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation 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 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 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 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 Hypersentivity 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 219 words ▾

ADVERSE REACTIONS Clinical Trial Experience: Adverse events reported in >1% of patients receiving albuterol sulfate and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table 1. Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg (0.042%) Albuterol Inhalation Solution (n = 115) 0.63 mg (0.021%) Albuterol 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 (0.042%) albuterol inhalation solution treatment group. No clinically relevant laboratory abnormalities related to albuterol inhalation solution administration were seen in this study. Postmarketing Experience: Metabolic acidosis has been reported after the use of albuterol 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.

🔄 Drug Interactions ~1 min read ▾

Drug Interactions: Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution. Albuterol inhalation solution 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, since the action of albuterol on the vascular system may be potentiated. Beta-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., 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 should be considered, although they should be administered with caution.

The ECG changes and/or hypokalemia that 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 dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. 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 ~1 min read ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C: Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis) and cleft palate formation in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis).

Cleft palate formation also occurred in 23 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg (approximately 60 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). A study in which pregnant rats were dosed with radiolabelled albuterol sulfate demonstrated that drug-related material was transferred from the maternal circulation to the fetus.

There are no adequate and well-controlled studies of the use of albuterol sulfate 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 reported in the offspring of patients being treated with albuterol.

Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.

🧒 Pediatric Use 95 words ▾

Pediatric Use: Safety and effectiveness of albuterol inhalation solution 1.25 mg (0.042%) and 0.63 mg (0.021%) have been established in pediatric patients between the ages of 2 and 12 years. The use of albuterol inhalation solution in these age groups is supported by evidence from adequate and well-controlled studies of albuterol inhalation solution in children age 6 to 12 years and published reports of albuterol sulfate trials in pediatric patients 3 years of age and older. The safety and effectiveness of albuterol inhalation solution in children below 2 years of age have not been established.

🆘 Overdosage 215 words ▾

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 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 580 times the maximum recommended daily inhalation dose of albuterol sulfate 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 on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.

🧬 Clinical Pharmacology ~1 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, 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 (0.021%) or 1.25 mg (0.042%) albuterol inhalation solution by nebulization have not been determined in children 2 to 12 years old.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Albuterol inhalation solution, USP is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg (0.021%) of albuterol (equivalent to 0.75 mg of albuterol sulfate in 3 mL) and 1.25 mg (0.042%) of albuterol (equivalent to 1.5 mg of albuterol sulfate in 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 1 unit-dose LDPE vial. Each strength of albuterol inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol inhalation solution, USP 0.021%* (0.63 mg* / 3 mL) (*potency expressed as albuterol) in unit-dose vials and is available in the following packaging configurations: NDC 64980-643-03 30 foil pouches, each containing 1 vial, total 30 vials per carton Albuterol inhalation solution, USP 0.042%* (1.25 mg* / 3 mL) (potency expressed as albuterol) in unit-dose vials and is available in the following packaging configurations: NDC 64980-644-02 25 foil pouches, each containing 1 vial, total 25 vials per carton NDC 64980-644-03 30 foil pouches, each containing 1 vial, total 30 vials per carton STORAGE: Store between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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 within one week.

Discard the vial if the solution is not colorless. Keep out of the reach of children. Rx Only Distributed by: Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816 For Customer Service, Call: 1-844-874-7464 Issued: 02/2025 IC 3032 Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172

📦 Storage and Handling 96 words ▾

STORAGE: Store between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. 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 within one week. Discard the vial if the solution is not colorless. Keep out of the reach of children.

Rx Only Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 For Customer Service, Call: 1-844-874-7464 Issued: 02/2025 IC 3032 Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172

📋 Description ~2 min read ▾

DESCRIPTION Albuterol inhalation solution, USP is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate USP. Albuterol sulfate USP 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 USP 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 is salbutamol. Albuterol inhalation solution, USP is supplied in two strengths in unit-dose vials.

Each unit-dose vial contains either 0.75 mg of albuterol sulfate USP (equivalent to 0.021% or 0.63 mg of albuterol) or 1.5 mg of albuterol sulfate USP (equivalent to 0.042% or 1.25 mg of albuterol) 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 and 5 (see HOW SUPPLIED ). Albuterol inhalation solution, USP does not require dilution prior to administration by nebulization.

For albuterol inhalation solution, USP 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 (0.042% or 1.25 mg strength) and 39% of albuterol (0.021% or 0.63 mg strength) at a mean flow rate of

3.6L/min. The mean nebulization time was 15 minutes or less. Albuterol inhalation solution, USP should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION ). Structure

💬 Information for Patients 191 words ▾

Information for Patients: The action of albuterol 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 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.

All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as albuterol inhalation solution include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about the use of albuterol inhalation solution.

Effective and safe use of albuterol inhalation solution includes an understanding of the way it should be administered. If the solution in the vial changes color or becomes cloudy, you should not use it. The drug compatibility (physical and chemical), clinical 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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: 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 potassium supplementation.

Information for Patients: The action of albuterol 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 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.

All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as albuterol inhalation solution include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about the use of albuterol inhalation solution.

Effective and safe use of albuterol inhalation solution includes an understanding of the way it should be administered. If the solution in the vial changes color or becomes cloudy, you should not use it. The drug compatibility (physical and chemical), clinical 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 short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution. Albuterol inhalation solution 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, since the action of albuterol on the vascular system may be potentiated. Beta-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., 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 should be considered, although they should be administered with caution.

The ECG changes and/or hypokalemia that 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 dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2 mg/kg (approximately equivalent to the maximum recommended daily inhalation d… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 52 words ▾

Nurisng Mothers: It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 129 words ▾

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 (0.021%) or 1.25 mg (0.042%) albuterol inhalation solution by nebulization have not been determined in children 2 to 12 years old.

🔬 Clinical Studies ~1 min read ▾

Clinical Trials: The safety and efficacy of albuterol 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 inhalation solution 0.63 mg (0.021%), albuterol inhalation solution 1.25 mg (0.042%), 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 or 0.042% group] and n=110 [0.63 mg or 0.021% 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. The onset of a 15% increase in FEV 1 over baseline for both doses of albuterol inhalation solution was seen at 30 minutes (the first post-dose assessment). The mean time to peak effect was approximately 30 to 60 minutes for both doses on day 1 and after 4 weeks of treatment.

The mean duration of effect, as measured by a >15% increase from baseline in FEV 1 , was approximately 2.5 hours for both doses on day 1 and approximately 2 hours for both doses after 4 weeks of treatment. In some patients, the duration of effect was as long as 6 hours. figure 1 figure 2

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 217 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2 mg/kg (approximately equivalent to the maximum recommended daily inhalation dose for albuterol sulfate on a mg/m 2 basis). In another study, this effect was blocked by the co-administration of propranolol, a non-selective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 500 mg/kg (approximately 140 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis).

In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 50 mg/kg (approximately 20 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH 1 strain mouse micronucleus assay.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 30 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication, as you may want to read them again. Albuterol inhalation solution should only be used under the direction of a physician.

Your physician and pharmacist have more information about albuterol inhalation solution and the condition for which it has been prescribed. Contact them if you have additional questions. Storing your medication: Store albuterol inhalation solution between 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Vials should be protected from light before use, therefore keep unused vials in the foil pouch. Once removed use within one week. Discard the vial if the solution is not colorless.

Keep out of reach of children. Do not use after the expiration date printed on the vial. Dose: Albuterol inhalation solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution.

No mixing or dilution is needed. Use new vial with each nebulizer treatment. FOR USE IN CHILDREN AGES 2 TO 12.

See accompanying prescribing information. Patient's Instruction For Use Remove one vial from the foil pouch. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).

3. Connect the nebulizer to the mouthpiece or face mask (Figure 2). 4.

Connect the nebulizer to the compressor. 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor.

6. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5-15 minutes). At this point, the treatment is finished.

7.Clean the nebulizer (see manufacturer's instructions). Note: Use only as directed by your physcian. More frequent administration or higher doses are not recommended. figure 3 figure 4 figure 5 figure 6 PATIENT INFORMATION Albuterol Inhalation Solution, USP 0.021%* (0.63 mg* / 3 mL) and 0.042%* (1.25mg* / 3mL) *Potency expressed as albuterol Prescription Only.

Read the patient information that comes with albuterol inhalation solution before using it and each time you get a refill for your child. There may be new information. This leaflet does not take the place of talking to your child’s doctor about your child’s medical condition or treatment.

What is albuterol inhalation solution? Albuterol inhalation solution is a medicine that is used for the relief of bronchospasms caused by asthma in children ages 2 to 12 years. Bronchospasm is the tightening and swelling of the muscles around the airways.

Albuterol inhalation solution can help relax these airway muscles for up to 6 hours so that your child may breathe more easily. Who should not use albuterol inhalation solution? Do not give your child albuterol inhalation solution if he or she is allergic to any of its ingredients.

The active ingredient is albuterol sulfate. See the end of this leaflet for a complete list of ingredients. What should I tell my child’s doctor before giving albuterol inhalation solution?

Tell your child’s doctor about all of your child’s medical conditions including if your child has: Heart problems High blood pressure Seizures A thyroid problem called hyperthyroidism Diabetes Tell your child’s doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. Albuterol inhalation solution and some other medicines can affect each other and may cause serious side effects. Especially tell your child’s doctor if your child is taking or using: Any short-acting bronchodilator medicines (sometimes called rescue inhalers) Epinephrine Medicines called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants or has stopped taking them in the past 2 weeks.

These medicines are usually used for mental problems. Medicines called beta-blockers (used for… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 40 words ▾

Principal Display Panel Carton (1.25* mg) NDC 64980-644-02 Carton (0.63mg*) NDC 64980-643-03 Carton Back Panel (1.25* mg and 0.63*mg) Pouch Label (1.25mg/3mL) NDC 64980-644-02 Pouch Label (0.63mg/3mL) NDC 64980-643-03 carton-1.25mg carton-0.63mg carton back panel 042 alb foil 021 alb foil

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 ✓ Available
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 Rising Pharma Holdings, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rising Pharma Holdings, Inc 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.
← 64980-0643-03 · Rising 64980-0645-03 · Rising →
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.