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Albuterol 4 mg Tablet, 500-count — NDC 70710-1062-5 (Billing 70710-1062-05)

by Zydus Pharmaceuticals USA Inc. · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Albuterol 4 mg Tablet from Zydus Pharmaceuticals USA Inc., marketed since Oct 2020 and currently FDA-listed.

NDC 70710-1062-05
🏷️ FDA NDC (as labeled) 70710-1062-5 billing pads the package segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.6733/unit — full pricing hub ↓
Product page 70710-1062-01 Also comes in: 100 tablets 70710-1062-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 70710-1062-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70710 labeler · 1062 product · 5 package
Package marketed since
Oct 23, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7071010625 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70710-1062-5
Product NDC 70710-1062
11-digit billing NDC 70710106205
RxCUI 197316, 197318
UNII 021SEF3731
Application # ANDA208884
SPL Set ID c3fa0068-fd12-45de-818e-e929fb45ba05
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 2020-10-23
Route ORAL
Dosage form TABLET
Substance ALBUTEROL SULFATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 44201010100310
GPI class Albuterol Sulfate
GCN Seq No 005034
GCN 20101
HICL code 002073
Ingredient (HICL) Albuterol Sulfate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5D
Therapeutic class — specific (HIC3) Beta-Adrenergic Agents
AHFS code 12:12.08.12
AHFS class Selective Beta-2-Adrenergic Agonists
FDB label name ALBUTEROL SULFATE 4 MG TAB
FDB brand name Albuterol Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005034
  • GCN: 20101
  • GPI-14 (Medi-Span): 44201010100310
  • HICL (First Databank): 002073
  • AHFS class code: 12:12.08.12
  • RxCUI (RxNorm): 197316
Why two NDCs? The FDA registers this code as 70710-1062-5 — 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 → 70710-1062-05. 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

Label name ALBUTEROL SULFATE 4 MG TAB Ingredient Albuterol Sulfate
📖 What it is MedlinePlus · NLM

Albuterol is used to prevent and treat wheezing, difficulty breathing, chest tightness, and coughing caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.

Read the full MedlinePlus article ↗
📗 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 may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Albuterol 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 eachPer 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 $0.6733 $336.65 / 500 tablets
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 Per unit Per pack Marketing startMarketing endStatus
70710-1062-01 70710-1062-1 Main listing 100 TABLET in 1 BOTTLE $0.4044 / ea $40.44 2020-10-23 — Active
70710-1062-05 You're viewing this 500 TABLET in 1 BOTTLE — — 2020-10-23 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 70710-1062-01?
Both are Albuterol 4 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 70710-1062-01 is the 100 tablets package.
What NDC number is used to bill for this package of Albuterol 4 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
albuterol sulfate 4 mg 53489-0177-01 Sun 100 tablets $0.404 AB Availability likely —
Albuterol Sulfate 4 mg 62135-0672-90 Chartwell 90 tablets $0.404 — Availability likely —
Albuterol 4 mg 64980-0443-01 Rising 100 tablets $0.404 AB Availability likely —
Albuterol 4 mg 75834-0274-01 Nivagen 100 tablets $0.435 — Discontinued —
albuterol sulfate 4 mg 51407-0368-01 Golden 100 tablets — AB FDA listed —
Albuterol 4 mg 59651-0334-01 Aurobindo 100 tablets — — FDA listed —
Albuterol 4 mg 63629-2611-01 Bryant 20 tablets — AB FDA listed —
Albuterol 4 mg 69238-1345-05 Amneal 500 tablets — AB FDA listed —
Albuterol 4 mgthis 70710-1062-05 Zydus 500 tablets — AB FDA listed —
Albuterol 4 mg 70771-1512-01 Zydus 100 tablets — AB FDA listed —
Albuterol 4 mg 71205-0899-00 Proficient 100 tablets — AB 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
Oct 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.

🧪 Avoiding an ingredient? See Albuterol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerZydus Pharmaceuticals USA Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA208884 (ANDA)
Labeler code70710
First marketedOct 2020
Product typeHuman Prescription Drug
Portfolio454 products on file

More NDCs from Zydus Pharmaceuticals USA Inc. labeler code 70710

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Albuterol tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION The following dosages of albuterol tablets are expressed in terms of albuterol base. Albuterol tablets Usual Dosage Pediatric Patients 6 to 12 Years of Age: For pediatric patients 6 to 12 years of age, the usual dosage is 2 mg three or four times a day. Adults and Pediatric Patients Over 12 Years of Age: For adults and pediatric patients over 12 years of age, the usual starting dosage is 2 or 4 mg three or four times a day.

Dosage Adjustment Pediatric Patients 6 to 12 Years of Age Who Fail to Res pond to the Initial Starting Dosage of 2 mg Four Times a Day: For pediatric patients from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses). Adults and Pediatric Patients Over 12 Years of Age: For adults and pediatric patients over 12 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond to lower dose.

The dosage should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated if a favorable response does not occur with the 4 mg initial dosage. Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators: An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually as tolerated to as much as 8 mg three or four times a day.

The total daily dose should not exceed 24 mg per day in pediatric patients from 6 to 12 years of age and 32 mg in adults and pediatric patients over 12 years of age.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.

⚠️ Warnings ~1 min read ▾

WARNINGS Paradoxical Bronchospasm Albuterol tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol tablets should be discontinued immediately and alternative therapy instituted. 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 tablets than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the 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.

Cardiovascular Effects Albuterol tablets, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of albuterol tablets at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.

The clinical significance of these findings is unknown. Therefore, albuterol tablets, like all 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, anaphylaxis and oropharyngeal edema.

Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol sulfate in children.

🤒 Adverse Reactions 187 words ▾

ADVERSE REACTIONS The adverse reactions to albuterol are similar in nature to those of other sympathomimetic agents. Albuterol tablets Adverse Experience Incidence (% of patients) in Adults and Children 6 Years of Age and Older Adverse Event Percent Incidence Central nervous system Nervousness 20% Tremor 20% Headache 7% Dizziness 2% Weakness 2% Sleeplessness 2% Irritability <1% Drowsiness <1% Restlessness <1% Cardiovascular Palpitations 5% Tachycardia 5% Flushing <1% Chest discomfort <1% Musculoskeletal Muscle cramps 3% Gastrointestinal Nausea 2% Genitourinary Difficulty in micturition <1% Cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema and antirhytmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of albuterol tablets.

In addition to those adverse reactions reported above, albuterol, like other sympathomimetic agents, can cause adverse reactions such as angina, central nervous system stimulation, drying or irritation of the oropharynx, hypertension, unusual taste, and vertigo. The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol tablets. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.

🔄 Drug Interactions 73 words ▾

Drug Interactions The concomitant use of albuterol tablets and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving albuterol tablets. Such concomitant use, however, should be individualized and not given on a routine basis.

If regular coadministration is required, then alternative therapy should be considered.

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous (sc) doses at and above 0.25mg/kg (corresponding to less than the maximum recommended daily oral dose for adults on a mg/m 2 basis), induced cleft palate formation in 5 of 111 (4.5%) fetuses. At an sc dose of 2.5 mg/kg (corresponding to less than the maximum recommended daily oral dose for adults on an mg/m 2 basis) albuterol sulfate induced cleft palate formation in 10 of 108 (9.3%) fetuses.

The drug did not induce cleft palate formation when administered at an sc dose, 0.025 mg/kg (significantly less than the maximum recommended daily oral dose for adults on an mg/m 2 basis). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg of isoproterenol (positive control) subcutaneously. A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a dose of 50 mg/kg (approximately 25 times the maximum recommended daily oral dose for adults on an mg/m 2 basis).

Studies in pregnant rats with tritiated albuterol demonstrated that approximately 10% of the circulating maternal drug is transferred to the fetus. Disposition in the fetal lungs is comparable to maternal lungs, but fetal liver disposition is 1% of the maternal liver levels. There are no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, 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.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., angina, hypertension tachycardia with rates up to 200 beats per minute, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, and insomnia. In addition, seizures, hypotension, arrhythmias, fatigue, malaise and hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol tablets.

Treatment consists of discontinuation of albuterol tablets 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 tablets.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 250 times the maximum recommended daily oral dose for adults on an mg/m 2 basis, and approximately 200 times the maximum recommended daily oral dose for children on a mg/m 2 basis). In mature rats, the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults on an mg/m 2 basis, and approximately 90 times the maximum recommended daily oral dose for children on an mg/m 2 basis).

In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 510 times the maximum recommended daily oral dose for adults on an mg/m 2 basis, and approximately 400 times the maximum recommended daily oral dose for children on an mg/m 2 basis).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY The primary action of beta-adrenergic agonist drugs, including albuterol, is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'- adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP) in beta-adrenergic cells. The cyclic AMP thus formed mediates the cellular responses. Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established (see WARNINGS ).

In controlled clinical trials, albuterol has been shown 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 ECG 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.

Preclinical 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 the plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the 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. Pharmacokinetics Albuterol is rapidly and well absorbed following oral administration. In studies involving normal volunteers, the mean steady-state peak and trough plasma levels of albuterol were 6.7 and 3.8 ng/mL, respectively, following dosing with a 2 mg albuterol tablet every 6 hours and 14.8 and 8.6 ng/mL, respectively following dosing with a 4 mg albuterol tablet every 6 hours.

Maximum albuterol plasma levels are usually obtained between 2 and 3 hours after dosing, and the elimination half-life is 5 to 6 hours. These data indicate that albuterol administered orally is dose proportional and exhibits dose independent pharmacokinetics. It has been shown that administration of a 4 mg albuterol extended-release tablets every 12 hours and 2 mg albuterol tablets every 6 hours for 5 days gave comparable peak albuterol levels and similar extent of absorption at steady state.

In other studies, the analysis of urine samples of patients given tritiated albuterol (4 to 10 mg) orally showed that 65% to 90% of the dose was excreted over 3 days, with the majority of the dose being excreted within the first 24 hours. Sixty percent of this radioactivity was shown to be the metabolite. Feces collected over this period contained 4% of the administered dose.

Clinical Trials In controlled clinical trials in patients with asthma, the onset of improvement in pulmonary function, as measured by maximum midexpiratory flow rate (MMEF), was noted within 30 minutes after a dose of albuterol tablets, with peak improvement occurring between 2 and 3… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 211 words ▾

HOW SUPPLIED Each albuterol tablet, USP for oral administration contains 2 mg or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. Albuterol tablets USP, 2 mg are white to off white colored, round shaped, flat faced, beveled edge uncoated tablets debossed with '10' on upper half of score line and '61' on lower half of score line on one side and plain on other side and are supplied as follows: NDC 70710-1061-1 in bottle of 100 tablets with child-resistant closure Albuterol tablets USP, 4 mg are white to off white colored, round shaped, flat faced, beveled edge uncoated tablets debossed with '10' on upper half of score line and '62' on lower half of score line on one side and plain on other side and are supplied as follows: NDC 70710-1062-1 in bottle of 100 tablets with child-resistant closure NDC 70710-1062-5 in bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, [email protected] or Tel.: 1-877-993-8779.

📋 Description 166 words ▾

DESCRIPTION Albuterol tablets, USP contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1 -[( tert -Butylamino)methyl]- 4-hydroxy- m -xylene-α,α'-diol sulfate (2:1) (salt) and the following structural formula: The molecular weight of albuterol sulfate is 576.71, and the molecular formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate, USP is a white or practically white powder.

It is freely soluble in water, slightly soluble in alcohol, in chloroform and in ether. The World Health Organization recommended name for albuterol base is salbutamol. Each albuterol tablet, USP for oral administration contains 2 mg or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively and following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize) and sodium starch glycolate.

FDA approved dissolution specification differs from the USP dissolution specification. Albuterol Tablet

💬 Information for Patients 184 words ▾

Information for Patients Patients being treated with albuterol tablets should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

The action of albuterol tablets may last up to 6 to 8 hours or longer. Albuterol tablets should not be taken more frequently than recommended. Do not increase the dose or frequency of albuterol tablets without consulting your physician.

If you find that treatment with albuterol tablets becomes less effective for symptomatic relief, your symptoms get worse, and/or you need to take the product more frequently than usual, you should seek medical attention immediately. While you are taking albuterol tablets, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness.

If you are pregnant or nursing, contact your physician about use of albuterol tablets. Effective and safe use of albuterol tablets includes an understanding of the way that it should be administered.

⚠️ 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. Clinically significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce 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.

Information for Patients Patients being treated with albuterol tablets should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

The action of albuterol tablets may last up to 6 to 8 hours or longer. Albuterol tablets should not be taken more frequently than recommended. Do not increase the dose or frequency of albuterol tablets without consulting your physician.

If you find that treatment with albuterol tablets becomes less effective for symptomatic relief, your symptoms get worse, and/or you need to take the product more frequently than usual, you should seek medical attention immediately. While you are taking albuterol tablets, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness.

If you are pregnant or nursing, contact your physician about use of albuterol tablets. Effective and safe use of albuterol tablets includes an understanding of the way that it should be administered. Drug Interactions The concomitant use of albuterol tablets and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects.

This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving albuterol tablets. Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.

Beta-Blockers Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol tablets, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma.

In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution. Diuretics The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Digoxin Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 52 words ▾

Nursing 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 203 words ▾

Pharmacokinetics Albuterol is rapidly and well absorbed following oral administration. In studies involving normal volunteers, the mean steady-state peak and trough plasma levels of albuterol were 6.7 and 3.8 ng/mL, respectively, following dosing with a 2 mg albuterol tablet every 6 hours and 14.8 and 8.6 ng/mL, respectively following dosing with a 4 mg albuterol tablet every 6 hours. Maximum albuterol plasma levels are usually obtained between 2 and 3 hours after dosing, and the elimination half-life is 5 to 6 hours.

These data indicate that albuterol administered orally is dose proportional and exhibits dose independent pharmacokinetics. It has been shown that administration of a 4 mg albuterol extended-release tablets every 12 hours and 2 mg albuterol tablets every 6 hours for 5 days gave comparable peak albuterol levels and similar extent of absorption at steady state. In other studies, the analysis of urine samples of patients given tritiated albuterol (4 to 10 mg) orally showed that 65% to 90% of the dose was excreted over 3 days, with the majority of the dose being excreted within the first 24 hours.

Sixty percent of this radioactivity was shown to be the metabolite. Feces collected over this period contained 4% of the administered dose.

📄 Package Label / Principal Display Panel 44 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70710-1061-1 in bottle of 100 tablets Albuterol tablets USP, 2 mg R x only 100 Tablets ZYDUS NDC 70710-1062-1 in bottle of 100 tablets Albuterol tablets USP, 4 mg R x only 100 Tablets ZYDUS Albuterol Tablets Albuterol Tablets

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets70710-1062-01 202 Rx · $8,389
500 tablets this page70710-1062-05 No Medicaid data
Drug total (last 4 qtrs): 202 Rx · 16,326 units · $8,389 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Albuterol — the ingredient across all brands.

Top reported reactions

Dyspnoea43,066
Asthma24,904
Cough20,393
Pneumonia16,838
Fatigue16,829
Headache15,673
Nausea14,713

Age at onset

Neonate195
Infant190
Child1,808
Adolescent1,419
Adult27,321
Elderly18,739

Reporter sex

296,553 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization84,969
Death18,878
Life-threatening9,557
Disabling7,466
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 29,949 14,171
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Zydus Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (70710-1062-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Pharmaceuticals USA 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.
← 70710-1061-01 · Zydus 70710-1068-01 · Zydus →
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.