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Ventolin HFA albuterol sulfate 90 ug Aerosol, Metered, 200-count — NDC 63187-026-18 (Billing 63187-0026-18)

by Proficient Rx LP · 200 AEROSOL, METERED in 1 INHALER

This is a package of 200 aerosols of Ventolin HFA albuterol sulfate 90 ug Aerosol, Metered from Proficient Rx LP, marketed since Jun 2006 and currently FDA-listed.

NDC 63187-0026-18
🏷️ FDA NDC (as labeled) 63187-026-18 billing pads the product segment with a zero
This package
Contains200-count Pack sizes2 compare ↓
Also priced by: Part D plans $3.02/unit — full pricing hub ↓
Product page 63187-0026-08 Also comes in: 60 aerosols 63187-026-08
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 63187-026-18 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63187 labeler · 026 product · 18 package
Package marketed since
Apr 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0363187026080
FDA record last changed
Jul 24, 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) 63187-026-18
Product NDC 63187-026
11-digit billing NDC 63187002618
RxCUI 801092, 801095, 859088, 2123076
UNII 021SEF3731
UPC 0363187026080
Application # NDA020983
SPL Set ID 6dc143e7-6bab-42c8-b3e9-9d604d202e73
Established class (EPC) beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-06-09
Route RESPIRATORY (INHALATION)
Dosage form AEROSOL, METERED
Substance ALBUTEROL SULFATE
TE code (Orange Book) AB3 · RLD · RS

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

GPI-14 44201010103410
GPI class Ventolin HFA
GCN Seq No 028090
GCN 22913
HICL code 002073
Ingredient (HICL) Albuterol Sulfate
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B6W
Therapeutic class — specific (HIC3) Beta-Adrenergic Agents, Inhaled, Short Acting
AHFS code 12:12.08.12
AHFS class Selective Beta-2-Adrenergic Agonists
FDB label name VENTOLIN HFA 90 MCG INHALER
FDB brand name Ventolin Hfa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 028090
  • GCN: 22913
  • GPI-14 (Medi-Span): 44201010103410
  • HICL (First Databank): 002073
  • AHFS class code: 12:12.08.12
  • RxCUI (RxNorm): 801092
Why two NDCs? The FDA registers this code as 63187-026-18 — 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 → 63187-0026-18. 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 VENTOLIN HFA 90 MCG INHALER Ingredient Albuterol Sulfate
📗 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 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 $3.02 $604.08 / 200 aerosols
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
63187-0026-08 63187-026-08 Main listing 60 AEROSOL, METERED in 1 INHALER 2015-04-01 — Active
63187-0026-18 You're viewing this 200 AEROSOL, METERED in 1 INHALER 2015-04-01 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 200-count package — 200 aerosol, metered in 1 inhaler.
How does this package differ from NDC 63187-0026-08?
Both are Ventolin HFA albuterol sulfate 90 ug Aerosol, Metered — the drug itself is identical. This page's package is the 200-count one, while NDC 63187-0026-08 is the 60 aerosols package.
What NDC number is used to bill for this package of Ventolin HFA albuterol sulfate 90 ug Aerosol, Metered?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuterol Sulfate HFA 90 ug 00093-3174-31 Teva 1 inhaler $1.540 AB2 Availability likely —
Albuterol Sulfate 90 ug 17270-0740-00 Armstrong 1 inhaler $1.540 AB2 Availability likely —
albuterol sulfate 90 ug 45802-0088-01 Padagis 1 inhaler $1.540 AB2 Availability likely —
Albuterol sulfate 90 ug 68180-0963-01 Lupin 1 canister $1.540 AB2 Availability likely —
Albuterol Sulfate HFA 90 ug 66993-0019-68 Prasco 1 inhaler $1.825 AB3 Availability likely —
Albuterol 90 ug 69097-0021-60 Cipla 1 inhaler $1.825 AB3 Availability likely —
Albuterol Sulfate 90 ug 76282-0679-42 Exelan 1 canister $2.120 AB1 Availability likely —
Albuterol Sulfate 90 ug 00054-0742-87 Hikma 1 canister $2.120 AB1 Availability likely —
Albuterol Sulfate 90 ug 60687-0662-91 American 1 canister $2.120 AB1 Availability likely —
Albuterol Sulfate 90 ug 69097-0142-60 Cipla 1 canister $2.120 AB1 Availability likely —
Ventolin Hfa 90 ug 00173-0682-20 GlaxoSmithKline 1 inhaler $3.035 AB3 Availability likely —
ProAir Digihaler 90 ug 59310-0117-20 Teva 1 inhaler $86.326 — FDA listed —
albuterol sulfate HFA 90 ug 50090-4137-00 A-S 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 51662-1513-01 HF 1 inhaler — AB2 FDA listed —
Ventolin Hfa 90 ugthis 63187-0026-18 Proficient 200 aerosols — AB3 FDA listed —
Albuterol Sulfate HFA 90 ug 71205-0211-85 Proficient 1 inhaler — AB2 FDA listed —
albuterol sulfate 90 ug 71205-0441-85 Proficient 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 71205-0732-85 Proficient 1 canister — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 76420-0088-01 Asclemed 1 inhaler — AB2 FDA listed —
Albuterol Sulfate 90 ug 76420-0531-01 Asclemed 200 aerosols — AB1 FDA listed —
Albuterol sulfate 90 ug 85766-0062-90 Sportpharm 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 68071-3902-02 NuCare 1 inhaler — AB2 FDA listed —
Albuterol Sulfate 90 ug 68788-8874-02 Preferred 1 canister — AB1 FDA listed —
Ventolin Hfa 90 ug 50090-1158-00 A-S 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 51662-1267-01 HF 1 inhaler — AB3 FDA listed —
Ventolin Hfa 90 ug 68071-1890-06 NuCare 60 aerosols — AB3 FDA listed —
Albuterol Sulfate HFA 90 ug 68071-4940-02 NuCare 200 aerosols — AB2 FDA listed —
Ventolin Hfa 90 ug 70518-1081-00 REMEDYREPACK 200 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 70518-1237-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
albuterol sulfate 90 ug 85766-0055-90 Sportpharm 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 50090-5231-00 A-S 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 50090-5735-01 A-S 96 canisters — AB1 FDA listed —
Albuterol Sulfate 90 ug 68788-4041-02 Preferred 1 inhaler — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 80425-0359-01 Advanced 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 50090-5179-00 A-S 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 70518-4496-00 REMEDYREPACK 1 inhaler — AB2 FDA listed —
Ventolin Hfa 90 ug 50090-1159-00 A-S 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 68788-8787-02 Preferred 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 80425-0266-01 Advanced 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 82804-0189-67 Proficient 1 canister — AB1 FDA listed —
Ventolin Hfa 90 ug 68071-1670-02 NuCare 200 aerosols — AB3 FDA listed —
Albuterol Sulate HFA 90 ug 70518-2072-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
Albuterol sulfate 90 ug 68788-8878-02 Preferred 1 canister — AB2 FDA listed —
Albuterol sulfate 90 ug 70518-3541-00 REMEDYREPACK 1 canister — AB2 FDA listed —
Albuterol sulfate 90 ug 76420-0350-90 Asclemed 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 85766-0020-90 Sportpharm 1 canister — AB1 FDA listed —
Albuterol sulfate 90 ug 68071-2300-02 NuCare 1 canister — AB2 FDA listed —
Albuterol Sulate HFA 90 ug 68071-4777-02 NuCare 200 aerosols — AB3 FDA listed —
Albuterol Sulfate 90 ug 85534-0039-00 HAWAII 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 68071-5312-06 NuCare 1 canister — AB1 FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2006
On the market since
Jun 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

LabelerProficient Rx LP
Application holderGLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
FDA applicationNDA020983 (NDA)
Labeler code63187
First marketedJun 2006
Product typeHuman Prescription Drug
Portfolio1,729 products on file

More NDCs from Proficient Rx LP labeler code 63187

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 96 words ▾

1 INDICATIONS AND USAGE VENTOLIN HFA is a beta 2 -adrenergic agonist indicated for: • Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1) • Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)

1.1Bronchospasm VENTOLIN ® HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

1.2Exercise-Induced Bronchospasm VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer VENTOLIN HFA by oral inhalation only. Shake VENTOLIN HFA well before each spray. FOR ORAL INHALATION ONLY. • Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours.

For some patients, 1 inhalation every 4 hours may be sufficient. (2.1) • Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise. (2.2) • Priming information: Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped.

To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. (2.3) • Cleaning information: At least once a week, wash the actuator with warm water and let it air-dry completely. (2.3)

2.1Bronchospasm For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children is 2 inhalations repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not recommended.

2.2Exercise-Induced Bronchospasm The usual dosage for adults and children 4 years of age and older is 2 inhalations 15 to 30 minutes before exercise.

2.3Administration Information Priming: Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.

Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week. Dose Counter: VENTOLIN HFA has a dose counter attached to the canister that starts at 204 or 64 and counts down each time a spray is released [see Dosage Forms and Strengths (3)] . When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed.

VENTOLIN HFA comes in a moisture-protective foil pouch, which should be removed prior to use. Discard VENTOLIN HFA when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first [see Dosage Forms and Strengths (3)] . See Patient Information tear-off leaflet for instructions on how to prime and clean the inhaler to ensure proper dosing and to prevent actuator orifice blockage.

💊 Dosage Forms and Strengths 110 words ▾

3 DOSAGE FORMS AND STRENGTHS VENTOLIN HFA is an inhalation aerosol. Each actuation contains 108 mcg albuterol sulfate (90 mcg albuterol base) from the mouthpiece. VENTOLIN HFA is supplied as an 18-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 200 actuations.

VENTOLIN HFA is also supplied as an 8-g pressurized aluminum canister with dose counter fitted with a blue plastic actuator and a blue strapcap; this canister contains 60 actuations. Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) from mouthpiece per actuation. Supplied in 18-g canister containing 200 actuations and 8-g canister containing 60 actuations.

(3)

⛔ Contraindications 54 words ▾

4 CONTRAINDICATIONS VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of VENTOLIN HFA. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. Hypersensitivity to albuterol sulfate or any of the ingredients of VENTOLIN HFA. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Paradoxical bronchospasm may occur and should be treated immediately with alternative therapy. (5.1) • Need for more doses of VENTOLIN HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. (5.2) • Cardiovascular effects may occur with beta-adrenergic agonists use.

Consider discontinuation of VENTOLIN HFA if these effects occur. Use with caution in patients with underlying cardiovascular disorders. (5.4) • Immediate hypersensitivity reactions may occur.

Discontinue VENTOLIN HFA if immediate hypersensitivity reactions occur. (5.6)

5.1Paradoxical Bronchospasm Inhaled albuterol sulfate can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, VENTOLIN HFA should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.

5.2Deterioration 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 VENTOLIN HFA than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3Use 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, to the therapeutic regimen.

5.4Cardiovascular Effects VENTOLIN HFA, like all other beta 2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, VENTOLIN HFA 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 relevance of these findings is unknown. Therefore, VENTOLIN HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol sulfate inhalation aerosol, as demonstrated by cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Discontinue VENTOLIN HFA if immediate hypersensitivity reactions occur.

5.7Coexisting Conditions VENTOLIN HFA, like other sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8Hypokalemia 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.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Use of VENTOLIN HFA may be associated with the following: • Paradoxical bronchospasm [see Warnings and Precautions (5.1)] • Cardiovascular effects [see Warnings and Precautions (5.4)] • Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)] • Hypokalemia [see Warnings and Precautions (5.8)] Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience The safety data described below reflects exposure to VENTOLIN HFA in 248 patients treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents is based upon 2 clinical trials in which 202 patients with asthma 12 years of age and older were treated with VENTOLIN HFA 2 inhalations 4 times daily for 12 weeks’ duration. The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other.

The data from pediatric patients are based upon 1 clinical trial in which 46 patients with asthma 4 to 11 years of age were treated with VENTOLIN HFA 2 inhalations 4 times daily for 2 weeks’ duration. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older: The two 12-week, randomized, double-blind studies in 610 adolescent and adult patients with asthma that compared VENTOLIN HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. Overall, the incidence and nature of the adverse reactions reported for VENTOLIN HFA and a CFC 11/12-propelled albuterol inhaler were comparable. Table 1 lists the incidence of all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these studies that occurred at a rate of 3% or greater in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group.

Table 1. Overall Adverse Reactions With ≥3% Incidence in 2 Large 12-Week Clinical Trials in Adolescents and Adults a Adverse Reaction Percent of Patients VENTOLIN HFA (n = 202) % CFC 11/12-Propelled Albuterol Inhaler (n = 207) % Placebo HFA-134a (n = 201) % Ear, nose, and throat Throat irritation 10 6 7 Upper respiratory inflammation 5 5 2 Lower respiratory Viral respiratory infections 7 4 4 Cough 5 2 2 Musculoskeletal Musculoskeletal pain 5 5 4 a This table includes all adverse reactions (whether considered by the investigator to be drug-related or unrelated to drug) that occurred at an incidence rate of at least 3.0% in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group.

Adverse reactions reported by less than 3% of the adolescent and adult patients receiving VENTOLIN HFA and by a greater proportion of patients receiving VENTOLIN HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to VENTOLIN HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitation and dizziness have also been observed with VENTOLIN HFA. Pediatric Patients: Results from the 2-week pediatric clinical study in patients with asthma 4 to 11 years of age showed that this pediatric population had an adverse reaction profile similar to that of the adolescent and adult populations.

Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients between birth and 4 years… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. • Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers.

(7.1) • Diuretics: Electrocardiographic changes and/or hypokalemia associated with diuretics may worsen with concomitant beta-agonists. Consider monitoring potassium levels. (7.2) • Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the vascular system.

Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. (7.4)

7.1Beta-Blockers Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as VENTOLIN HFA, but may produce severe bronchospasm in patients with asthma. 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 should be considered, although they should be administered with caution.

7.2Diuretics 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 relevance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics. Consider monitoring potassium levels.

7.3Digoxin 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 relevance of these findings for patients with obstructive airway disease who are receiving inhaled 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.

7.4Monoamine Oxidase Inhibitors or Tricyclic Antidepressants VENTOLIN HFA 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, because the action of albuterol on the vascular system may be potentiated. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of VENTOLIN HFA or albuterol sulfate in pregnant women. 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. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity.

VENTOLIN HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at exposures approximately equal to the maximum recommended human dose (MRHD) for adults on a mg/m 2 basis and in 10 of 108 (9.3%) fetuses at approximately 8 times the MRHD. Similar effects were not observed at approximately one eleventh of the MRHD.

Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). In a rabbit reproduction study, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 680 times the MRHD. In another rabbit study, an albuterol sulfate/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHD [see Animal Toxicology and/or Pharmacology (13.2)] .

8.2Labor and Delivery Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

8.3Nursing Mothers Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of VENTOLIN HFA are excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of VENTOLIN HFA by nursing mothers, 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. Caution should be exercised when VENTOLIN HFA is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of VENTOLIN HFA in children 4 years of age and older has been established based upon two 12-week clinical trials in patients 12 years of age and older with asthma and one 2-week clinical trial in patients 4 to 11 years of age with asthma [see Clinical Studies (14.1), Adverse Reactions (6.1)] . The safety and effectiveness of VENTOLIN HFA in children under 4 years of age has not been established. Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients under 4 years of age and the findings are described below.

Two 4-week randomized, double-blind, placebo-controlled studies were conducted in 163 pediatric patients from birth to 48 months of age with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). VENTOLIN HFA or placebo HFA was delivered with either an AeroChamber Plus ® Valved Holding Chamber or an Optichamber ® Valved Holding Chamber with mask 3 times daily. In one study, VENTOLIN HFA 90 mcg (N = 26), VENTOLIN HFA 180 mcg (N = 25), and placebo HFA (N = 26) were administered to children between 24 and 48 months of age.

In the second study, VENTOLIN HFA 90 mcg (N = 29), VENTOLIN HFA 180 mcg (N = 29), and placebo HFA (N = 28) were administered to children between birth and 24 months of age. Over the 4-week treatment per… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of VENTOLIN HFA or albuterol sulfate in pregnant women. 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. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established. Animal reproduction studies in mice and rabbits revealed evidence of teratogenicity.

VENTOLIN HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at exposures approximately equal to the maximum recommended human dose (MRHD) for adults on a mg/m 2 basis and in 10 of 108 (9.3%) fetuses at approximately 8 times the MRHD. Similar effects were not observed at approximately one eleventh of the MRHD.

Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). In a rabbit reproduction study, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 680 times the MRHD. In another rabbit study, an albuterol sulfate/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHD [see Animal Toxicology and/or Pharmacology (13.2)] .

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of VENTOLIN HFA in children 4 years of age and older has been established based upon two 12-week clinical trials in patients 12 years of age and older with asthma and one 2-week clinical trial in patients 4 to 11 years of age with asthma [see Clinical Studies (14.1), Adverse Reactions (6.1)] . The safety and effectiveness of VENTOLIN HFA in children under 4 years of age has not been established. Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients under 4 years of age and the findings are described below.

Two 4-week randomized, double-blind, placebo-controlled studies were conducted in 163 pediatric patients from birth to 48 months of age with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). VENTOLIN HFA or placebo HFA was delivered with either an AeroChamber Plus ® Valved Holding Chamber or an Optichamber ® Valved Holding Chamber with mask 3 times daily. In one study, VENTOLIN HFA 90 mcg (N = 26), VENTOLIN HFA 180 mcg (N = 25), and placebo HFA (N = 26) were administered to children between 24 and 48 months of age.

In the second study, VENTOLIN HFA 90 mcg (N = 29), VENTOLIN HFA 180 mcg (N = 29), and placebo HFA (N = 28) were administered to children between birth and 24 months of age. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving VENTOLIN HFA 90 mcg, VENTOLIN HFA 180 mcg, and placebo in either study. In a third study, VENTOLIN HFA was evaluated in 87 pediatric patients younger than 24 months of age for the treatment of acute wheezing.

VENTOLIN HFA was delivered with an AeroChamber Plus Valved Holding Chamber in this study. There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between VENTOLIN HFA 180 mcg and VENTOLIN HFA 360 mcg. In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA via holding chambers with facemasks.

The studies were conducted with 2 different holding chambers with facemasks (small and medium size). The in vitro study data when simulated to patients suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with facemask will be comparable to the dose delivered in adults without a spacer and facemask per kilogram of body weight (Table 2). However, clinical studies in children under 4 years of age described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age-group or VENTOLIN HFA is not effective in this age-group.

The safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children under 4 years of age has not been demonstrated. Table 2. In Vitro Medication Delivery Through AeroChamber Plus ® Valved Holding Chamber With a Facemask Age Facemask Flow Rate (L/min) Holding Time (seconds) Mean Medication Delivery Through AeroChamber Plus (mcg/actuation) Body Weight 50 th Percentile (kg) a Medication Delivered per Actuation (mcg/kg) b 6 to 12 Months Small 4.9 0 2 5 10 18.2 19.8 13.8 15.4 7.5-9.9 1.8-2.4 2.0-2.6 1.4-1.8 1.6-2.1 2 to 5 Years Small 8.0 0 2 5 10 17.8 16.0 16.3 18.3 12.3-18.0 1.0-1.4 0.9-1.3 0.9-1.3 1.0-1.5 2 to 5 Years Medium 8.0 0 2 5 10 21.1 15.3 18.3 18.2 12.3-18.0 1.2-1.7 0.8-1.2 1.0-1.5 1.0-1.5 >5 Years Medium 12.0 0 2 5 10 26.8 20.9 19.6 20.3 18.0 1.5 1.2 1.1 1.1 a Centers for Disease Control growth charts, developed by the National Center for Health Statistics in collaboration with the National Center for Chronic Disease Prevention and Health Promotion (2000).

Ranges correspond to the average of the 50 th percentile weight for boys and girls at the ages indicated. b A single inhalation of VENTOLIN HFA in a 70-kg adult without use of a valved holding chamber and facemask delivers approximately 90 mcg, or 1.3 mcg/kg.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Clinical studies of VENTOLIN HFA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~1 min read ▾

10 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., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, sleeplessness. Hypokalemia and metabolic acidosis may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of VENTOLIN HFA.

Treatment consists of discontinuation of VENTOLIN HFA 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 VENTOLIN HFA.

The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 3,200 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis).

In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6,400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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% of cardiac beta-adrenergic receptors. The precise function of these receptors has not been established [see Warnings and Precautions (5.4)] .

Activation of beta 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3′,5′-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles.

Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.

Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [see Warnings and Precautions (5.4)] .

12.2Pharmacokinetics The systemic levels of albuterol are low after inhalation of recommended doses. A study conducted in 12 healthy male and female subjects using a higher dose (1,080 mcg of albuterol base) showed that mean peak plasma concentrations of approximately 3 ng/mL occurred after dosing when albuterol was delivered using propellant HFA-134a. The mean time to peak concentrations (T max ) was delayed after administration of VENTOLIN HFA (T max = 0.42 hours) as compared to CFC-propelled albuterol inhaler (T max = 0.17 hours).

Apparent terminal plasma half-life of albuterol is approximately 4.6 hours. No further pharmacokinetic studies for VENTOLIN HFA were conducted in neonates, children, or elderly subjects.

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action 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% of cardiac beta-adrenergic receptors. The precise function of these receptors has not been established [see Warnings and Precautions (5.4)] .

Activation of beta 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3′,5′-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles.

Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.

Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [see Warnings and Precautions (5.4)] .

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol is supplied in the following packs as a pressurized aluminum canister fitted with a counter with a blue plastic actuator and a blue strapcap packaged within a moisture-protective foil pouch that also contains a desiccant: NDC 63187-026-08 8-g institutional pack canister containing 60 actuations Before using, VENTOLIN HFA should be removed from the moisture-protective foil pouch. The pouch and desiccant should be discarded. VENTOLIN HFA should be discarded 12 months after removal from the pouch.

Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. To prime the inhaler, release 4 sprays into the air away from the face, shaking well before each spray. The inhaler should be primed before using it for the first time, when the inhaler has not been used for more than 2 weeks, or when it has been dropped.

After priming, each actuation delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week [see the Patient Information tear‑off leaflet]. The blue actuator supplied with VENTOLIN HFA should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA canister.

VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 64 and counts down each time a spray is released. The correct amount of medication in each inhalation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate.

VENTOLIN HFA should be discarded when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first. Never immerse the canister in water to determine the amount of drug remaining in the canister. Keep out of reach of children.

Avoid spraying in eyes. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame.

Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Store between 15° and 25°C (59° and 77°F).

Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL BEFORE EACH SPRAY.

VENTOLIN HFA does not contain chlorofluorocarbons (CFCs) as the propellant.

📋 Description ~1 min read ▾

11 DESCRIPTION The active component of VENTOLIN HFA is 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 chemical structure: Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . It is soluble in water and slightly soluble in ethanol.

The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a pressurized metered-dose aerosol unit fitted with a counter. VENTOLIN HFA is intended for oral inhalation only.

Each unit contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation.

To prime the inhaler, release 4 sprays into the air away from the face, shaking well before each spray. The inhaler should be primed before using it for the first time, when it has not been used for more than 2 weeks, or when it has been dropped. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece).

Each 18-g canister provides 200 inhalations. Each 8-g canister provides 60 inhalations. This product does not contain chlorofluorocarbons (CFCs) as the propellant.

Chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use).

17.1Frequency of Use The action of VENTOLIN HFA should last up to 4 to 6 hours. VENTOLIN HFA should not be used more frequently than recommended. Do not increase the dose or frequency of doses of VENTOLIN HFA without consulting the physician.

If patients find that treatment with VENTOLIN HFA becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.

17.2Priming and Cleaning Priming: Patients should be instructed that priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Patients should prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, patients should release 4 sprays into the air away from the face, shaking well before each spray.

Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, patients should be instructed to wash the actuator and dry thoroughly at least once a week. Patients should be informed that detailed cleaning instructions are included in the Patient Information leaflet.

17.3Dose Counter Patients should be informed that VENTOLIN HFA has a dose counter that starts at 204 or 64 and counts down each time a spray is released. Patients should be informed to discard VENTOLIN HFA when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first. When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed.

Patients should never try to alter the numbers or remove the counter from the metal canister. Patients should never immerse the canister in water to determine the amount of drug remaining in the canister.

17.4Paradoxical Bronchospasm Patients should be informed that VENTOLIN HFA can produce paradoxical bronchospasm. If paradoxical bronchospasm occurs, patients should discontinue VENTOLIN HFA.

17.5Concomitant Drug Use While patients are using VENTOLIN HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician.

17.6Common Adverse Effects Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.

17.7Pregnancy Patients who are pregnant or nursing should contact their physicians about the use of VENTOLIN HFA. VENTOLIN is a registered trademark of GlaxoSmithKline. AeroChamber Plus is a registered trademark of Monaghan Medical Inc. OptiChamber is a registered trademark of Respironics Inc. GlaxoSmithKline Research Triangle Park, NC 27709 ©2012, GlaxoSmithKline. All rights reserved. VNT:8PI

🍼 Nursing Mothers 98 words ▾

8.3Nursing Mothers Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of VENTOLIN HFA are excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of VENTOLIN HFA by nursing mothers, 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. Caution should be exercised when VENTOLIN HFA is administered to a nursing woman.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Bronchospasm Associated With Asthma Adult and Adolescent Patients 12 Years of Age and Older: The efficacy of VENTOLIN HFA was evaluated in two 12-week, randomized, double-blind, placebo controlled trials in patients 12 years of age and older with mild to moderate asthma. These trials included a total of 610 patients (323 males, 287 females). In each trial, patients received 2 inhalations of VENTOLIN HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo 4 times daily for 12 weeks’ duration.

Patients taking the HFA-134a placebo inhaler also took VENTOLIN HFA for asthma symptom relief on an as-needed basis. Some patients who participated in these clinical trials were using concomitant inhaled steroid therapy. Efficacy was assessed by serial forced expiratory volume in 1 second (FEV 1 ).

In each of these trials, 2 inhalations of VENTOLIN HFA produced significantly greater improvement in FEV 1 over the pretreatment value than placebo. Results from the 2 clinical trials are described below. In a 12-week, randomized, double-blind study, VENTOLIN HFA (101 patients) was compared to CFC 11/12-propelled albuterol (99 patients) and an HFA-134a placebo inhaler (97 patients) in adolescent and adult patients 12 to 76 years of age with mild to moderate asthma.

Serial FEV 1 measurements [shown below as percent change from test-day baseline at Day 1 (n = 297) and at Week 12 (n = 249)] demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in FEV 1 over the pretreatment value than placebo. FEV 1 as Percent Change From Predose in a Large, 12-Week Clinical Trial Day 1 Week 12 In the responder population (≥15% increase in FEV 1 within 30 minutes postdose) treated with VENTOLIN HFA, the mean time to onset of a 15% increase in FEV 1 over the pretreatment value was 5.4 minutes, and the mean time to peak effect was 56 minutes.

The mean duration of effect as measured by a 15% increase in FEV 1 over the pretreatment value was approximately 4 hours. In some patients, duration of effect was as long as 6 hours. The second 12-week randomized, double-blind study was conducted to evaluate the efficacy and safety of switching patients from CFC 11/12-propelled albuterol to VENTOLIN HFA.

During the 3-week run-in phase of the study, all patients received CFC 11/12-propelled albuterol. During the double-blind treatment phase, VENTOLIN HFA (91 patients) was compared to CFC 11/12-propelled albuterol (100 patients) and an HFA-134a placebo inhaler (95 patients) in adolescent and adult patients with mild to moderate asthma. Serial FEV 1 measurements demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in pulmonary function than placebo.

The switching from CFC 11/12-propelled albuterol inhaler to VENTOLIN HFA did not reveal any clinically significant changes in the efficacy profile. In the 2 adult studies, the efficacy results from VENTOLIN HFA were significantly greater than placebo and were clinically comparable to those achieved with CFC 11/12-propelled albuterol, although small numerical differences in mean FEV 1 response and other measures were observed. Physicians should recognize that individual responses to beta-adrenergic agonists administered via different propellants may vary and that equivalent responses in individual patients should not be assumed.

Pediatric Patients 4 Years of Age: The efficacy of VENTOLIN HFA was evaluated in one 2-week, randomized, double-blind, placebo-controlled trial in 135 pediatric patients 4 to 11 years of age with mild to moderate asthma. In this trial, patients received VENTOLIN HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo. Serial pulmonary function measurements demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in pulmonary function than placebo and that there were no significant differences between the groups treated with VENTOLIN HFA and CFC 11/12-propelled albuterol.

In the res… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~3 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2.0 mg/kg (approximately 14 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In another study this effect was blocked by the coadministration 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 of up to 500 mg/kg (approximately 1,700 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 110 times the maximum recommended daily inhalation dose for children 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 AH1 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 340 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).

13.2Animal Toxicology and/or Pharmacology Preclinical: Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5.0% 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 relevance of these findings is unknown. Propellant HFA-134a is devoid of pharmacological activity except at very high doses in animals (380 to 1,300 times the maximum human exposure based on comparisons of AUC values), primarily producing ataxia, tremors, dyspnea, or salivation. These are similar to effects produced by the structurally related CFCs, which have been used extensively in metered-dose inhalers.

In animals and humans, propellant HFA-134a was found to be rapidly absorbed and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in animals and 5 to 7 minutes in humans. Time to maximum plasma concentration (T max ) and mean residence time are both extremely short, leading to a transient appearance of HFA-134a in the blood with no evidence of accumulation. Reproductive Toxicology Studies: A study in CD-1 mice given albuterol sulfate 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 for adults on a mg/m 2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately 8 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).

The drug did not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg of isoproterenol (positive control). A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 fetuses (37%) when albuterol sulfate wa… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2.0 mg/kg (approximately 14 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In another study this effect was blocked by the coadministration 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 of up to 500 mg/kg (approximately 1,700 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 110 times the maximum recommended daily inhalation dose for children 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 AH1 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 340 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

PHARMACIST—DETACH HERE AND GIVE LEAFLET TO PATIENT Patient Information VENTOLIN ® HFA (vent′ o-lin) (albuterol sulfate) Inhalation Aerosol Read this Patient Information before you start using VENTOLIN HFA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is VENTOLIN HFA? VENTOLIN HFA is a prescription medicine used in people 4 years of age and older to: • treat or prevent bronchospasm in people who have reversible obstructive airway disease • prevent exercise-induced bronchospasm It is not known if VENTOLIN HFA is safe and effective in children under 4 years of age. Who should not use VENTOLIN HFA?

Do not use VENTOLIN HFA if you are allergic to albuterol sulfate or any of the ingredients in VENTOLIN HFA. See the end of this Patient Information leaflet for a complete list of ingredients in VENTOLIN HFA. What should I tell my healthcare provider before I use VENTOLIN HFA?

Before you use VENTOLIN HFA, tell your healthcare provider if you: • have heart problems • have high blood pressure (hypertension) • have convulsions (seizures) • have thyroid problems • have diabetes • have low potassium levels in your blood • are pregnant or plan to become pregnant. It is not known if VENTOLIN HFA will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed.

It is not known if VENTOLIN HFA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using VENTOLIN HFA. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

VENTOLIN HFA and other medicines may affect each other and cause side effects. VENTOLIN HFA may affect the way other medicines work, and other medicines may affect the way VENTOLIN HFA works. Especially tell your healthcare provider if you take: • other inhaled medicines or asthma medicines • beta-blocker medicines • diuretics • digoxin • monoamine oxidase inhibitors • tricyclic antidepressants Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use VENTOLIN HFA? • For detailed instructions, see “ Instructions for Use ” at the end of this Patient Information. • Use VENTOLIN HFA exactly as your healthcare provider tells you to use it. • Do not increase your dose or take extra doses of VENTOLIN HFA without first talking to your healthcare provider. • If your child needs to use VENTOLIN HFA, watch your child closely to make sure your child uses the inhaler correctly.

Your healthcare provider will show you how your child should use VENTOLIN HFA. • Each dose of VENTOLIN HFA should last up to 4 hours to 6 hours. • Get medical help right away if VENTOLIN HFA no longer helps your symptoms. • Get medical help right away if your symptoms get worse or if you need to use your inhaler more often. • While you are using VENTOLIN HFA, use other inhaled medicines and asthma medicines only as directed by your healthcare provider. • Call your healthcare provider if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days.

Your healthcare provider may need to give you another medicine to treat your symptoms. What are the possible side effects of VENTOLIN HFA? VENTOLIN HFA may cause serious side effects, including: • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm).

If this happens, stop using VENTOLIN HFA and call your healthcare provider or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine. • heart problems, including faster heart rate and high… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 63187-026-08

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 Ventolin HFA — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Ventolin HFA. 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
$21.3M
Claims incl. refills
319.4K
Beneficiaries
211.9K
Spend / beneficiary
$100.51
Spend / claim
$66.68
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.

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 VENTOLIN HFA (this brand).

Top reported reactions

Dyspnoea27,848
Asthma17,201
Cough13,514
Fatigue10,445
Pneumonia10,322
Headache9,770
Wheezing9,302

Age at onset

Neonate80
Infant79
Child1,074
Adolescent971
Adult18,618
Elderly11,416

Reporter sex

178,986 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization43,619
Death9,189
Life-threatening3,898
Disabling3,648
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 19,186 9,164
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 Proficient Rx LP. 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 60 aerosols (63187-0026-08). 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?
Proficient Rx LP 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.
← 63187-0025-15 · Proficient 63187-0028-10 · Proficient →
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.