Albuterol 4 mg Tablet, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the beta2-Adrenergic Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
- What exactly does albuterol do, and when should I use it?
- That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
- The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Albuterol — tap one for details:
Albuterol may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per 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 | $673.30 / 1000 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| albuterol sulfate 4 mg 53489-0177-01 | Sun | 100 tablets | $0.337 | AB | Availability likely | — |
| Albuterol Sulfate 4 mg 62135-0672-90 | Chartwell | 90 tablets | $0.337 | — | Availability likely | — |
| Albuterol 4 mg 64980-0443-01 | Rising | 100 tablets | $0.337 | AB | Availability likely | — |
| Albuterol 4 mg 70710-1062-01 | Zydus | 100 tablets | $0.337 | AB | Availability likely | — |
| Albuterol 4 mg 75834-0274-01 | Nivagen | 100 tablets | $0.435 | — | FDA listed | — |
| 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 mg 70771-1512-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Albuterol 4 mgthis 71205-0899-11 | Proficient | 1000 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71205-0899-00 | 100 TABLET in 1 BOTTLE (71205-899-00) | 2021-07-30 | Active |
| 71205-0899-11 You're viewing this | 1000 TABLET in 1 BOTTLE (71205-899-11) | 2021-07-30 | Active |
| 71205-0899-30 | 30 TABLET in 1 BOTTLE (71205-899-30) | 2021-07-30 | Active |
| 71205-0899-55 | 500 TABLET in 1 BOTTLE (71205-899-55) | 2021-07-30 | Active |
| 71205-0899-60 | 60 TABLET in 1 BOTTLE (71205-899-60) | 2021-07-30 | Active |
| 71205-0899-90 | 90 TABLET in 1 BOTTLE (71205-899-90) | 2021-07-30 | Active |
You're viewing the largest of 6 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71205-0899-11?
What is the difference between NDC 71205-0899-11 and NDC 71205-0899-30?
What NDC number is used to bill for this package of Albuterol 4 mg Tablet?
🧭 About this NDC listing & data coverage
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) | ✓ 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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Albuterol tablets 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 ▾
DOSAGE & ADMINISTRATION The following dosages of Albuterol tablets are expressed in terms of albuterol base. 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 Respond 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 respondto the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increasedstepwise, 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 ▾
CONTRAINDICATIONS Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of their components.
⚠️ Warnings ▾
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 ▾
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 arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extraystoles) 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.
🆘 Overdosage ▾
OVERDOSAGE The expected symptoms with overdosage are those of excessive bet a -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 bet a -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 an 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 ▾
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.
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 plasm 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. 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 hours.
In controlled clinical trials in which measurements were conducted for 6 hours, significant clinical improvement in pulmonary function (defined as maintaining a 15% or more increase in forced expiratory volume in 1 second [FEV 1 ] and a 20% or mor…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Each Albuterol tablet, USP for oral administration contains 2 mg or 4 mg albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. Albuterol Tablets, USP containing 2 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with “AC 2” on one side and plain on other side. They are available as follows: NDC 71205-898-30 Bottles of 30 tablets NDC 71205-898-60 Bottles of 60 tablets NDC 71205-898-90 Bottles of 90 tablets NDC 71205-898-00 Bottles of 100 tablets NDC 71205-898-55 Bottles of 500 tablets NDC 71205-898-11 Bottles of 1000 tablets Albuterol Tablets, USP containing 4 mg albuterol as the sulfate are white, round shaped, scored tablets debossed with “AC 4” on one side and plain on other side.
They are available as follows: NDC 71205-899-30 Bottles of 30 tablets NDC 71205-899-60 Bottles of 60 tablets NDC 71205-899-90 Bottles of 90 tablets NDC 71205-899-00 Bottles of 100 tablets NDC 71205-899-55 Bottles of 500 tablets NDC 71205-899-11 Bottles of 1000 tablets Store Albuterol tablets at 20° to 25°C (68° to 77°F). [See USP for controlled Room Temperature.] Protect from light Manufactured by Appco Pharma LLC. Piscataway, New Jersey 08854 Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 01/2019 Store Albuterol tablets at 20° to 25°C (68° to 77°F). [See USP for controlled Room Temperature.] Protect from light Manufactured by Appco Pharma LLC.
Piscataway, New Jersey 08854 Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 01/2019
📋 Description ▾
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 4-hydroxy- 3-hydroxymethyl-α-[(tert-butylamino) methyl]benzyl alcohol, sulfate and the following structural formula: The molecular weight of albuterol sulfate is 576.70, and the molecular formula is (C 13 H 21 N O 3 ) 2 • H 2 S O 4 . Albuterol sulfate, USP is a white or practically white powder, freely soluble in water and slightly soluble in alcohol, in chloroform, and ether.
Each Albuterol tablet for oral administration contains 2 or 4 mg of albuterol as 2.4 mg or 4.8 mg of albuterol sulfate, USP respectively. The inactive ingredients for Albuterol tablets, 2 mg and 4 mg include: co-processed starch , lactose hydrate , magnesium stearate, partially pregelatinized maize starch and sodium lauryl sulfate. structure