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ALBUTEROL SULFATE 90 ug Aerosol, Metered — NDC 51662-1267-01 package photo

ALBUTEROL SULFATE 90 ug Aerosol, Metered

by HF Acquisition Co LLC, DBA HealthFirst · 1 INHALER in 1 CARTON (51662-1267-1) / 60 AEROSOL, METERED in 1 INHALER
NDC 51662-1267-01
🏷️ FDA NDC (as labeled) 51662-1267-1 billing pads the package segment with a zero
This package
Contains60 aerosol, metered in 1 inhaler Pack sizes2 compare ↓
Also comes in: 60 aerosols 51662-1267-09
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

🆔 Identity & classification

FDA NDC (as labeled) 51662-1267-1
Product NDC 51662-1267
11-digit billing NDC 51662126701
RxCUI 801092
UNII 021SEF3731
UPC 0301730682246
Application # NDA020983
SPL Set ID 767a1504-1e04-1e06-e053-2a91aa0aa4b6
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 2018-09-22
Route RESPIRATORY (INHALATION)
Dosage form AEROSOL, METERED
Substance ALBUTEROL SULFATE
TE code (Orange Book) AB3 · RLD · RS
Why two NDCs? The FDA registers this code as 51662-1267-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51662-1267-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the beta2-Adrenergic Agonist class.

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

🏭 Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderGLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
FDA applicationNDA020983 (NDA)
Labeler code51662
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio333 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • 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...
📖 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.

🧪 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.

  • UNII DH9E53K1Y8
    A synthetic fluorinated hydrocarbon used primarily as a propellant or aerosol dispersant in pressurized inhaler formulations to help deliver medication to the lungs.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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.

💲 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuterol Sulfate HFA 90 ug 00093-3174-31 Teva 1 inhaler $1.553 AB2 Availability likely —
Albuterol Sulfate 90 ug 17270-0740-00 Armstrong 1 inhaler $1.553 AB2 Availability likely —
albuterol sulfate 90 ug 45802-0088-01 Padagis 1 inhaler $1.553 AB2 Availability likely —
Albuterol sulfate 90 ug 68180-0963-01 Lupin 1 canister $1.553 AB2 Availability likely —
Albuterol Sulfate HFA 90 ug 66993-0019-68 Prasco 1 inhaler $1.819 AB3 Availability likely —
Albuterol 90 ug 69097-0021-60 Cipla 1 inhaler $1.819 AB3 Availability likely —
Albuterol Sulfate 90 ug 76282-0679-42 Exelan 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 00054-0742-87 Hikma 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 60687-0662-91 American 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 69097-0142-60 Cipla 1 canister $2.126 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 ug 63187-0026-08 Proficient 60 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 ugthis 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.

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

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

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Dyspnoea42,946
Asthma24,941
Cough20,428
Fatigue16,816
Pneumonia16,771
Headache15,685
Nausea14,693

Reporter sex

297,526 reports

Serious outcomes

Death18,793
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 29,981 14,207
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51662-1267-01 You're viewing this 1 INHALER in 1 CARTON (51662-1267-1) / 60 AEROSOL, METERED in 1 INHALER 2018-09-22 Active
51662-1267-09 60 AEROSOL, METERED in 1 INHALER (51662-1267-9) 2018-09-22 Active

Pack size FAQ

What quantity is in NDC 51662-1267-01?
NDC 51662-1267-01 is listed by the FDA — 1 inhaler in 1 carton / 60 aerosol, metered in 1 inhaler.
What NDC number is used to bill for this package of ALBUTEROL SULFATE 90 ug Aerosol, Metered?
Bill NDC 51662-1267-01 — the 11-digit billing format is 51662126701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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 FDA registers it as 51662-1267-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51662-1267-01, written without dashes as 51662126701. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51662-1267-01, the first segment (51662) is the labeler code FDA assigned to HF Acquisition Co LLC, DBA HealthFirst; the middle segment (1267) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 aerosols (51662-1267-09). 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?
HF Acquisition Co LLC, DBA HealthFirst is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 51 words ▾

1 INDICATIONS & USAGE

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

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

⏱️ Dosage and Administration 190 words ▾

2 DOSAGE & ADMINISTRATION

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 greater number of inhalations is not recommended.

2.2Exercise-Induced Bronchospasm For prevention of exercise-induced bronchospasm, the usual dosage for adults and children aged 4 years and older is 2 inhalations 15 to 30 minutes before exercise.

2.3Administration Information VENTOLIN HFA should be administered by the orally inhaled route only. 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.

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS & STRENGTHS Inhalation Aerosol. Blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister containing 60 or 200 metered inhalations and fitted with a counter. Each actuation delivers 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece.

⛔ Contraindications 28 words ▾

4 CONTRAINDICATIONS VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions 5- (5.6), Description ( 11 )].

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Paradoxical Bronchospasm VENTOLIN HFA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with VENTOLIN HFA, it should be discontinued immediately and alternative therapy should be 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 beta2-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 (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of VENTOLIN HFA [see Contraindications ( 4 )].

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 Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology 12- (12.1)]. The decrease in serum potassium 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- (5.1)] • Cardiovascular effects [see Warnings and Precautions 5- (5.4)] • Immediate hypersensitivity reactions [see Warnings and Precautions 5- (5.6)] • Hypokalemia [see Warnings and Precautions 5- (5.8)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflects exposure to VENTOLIN HFA in 248 subjects 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 subjects with asthma aged 12 years 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 subjects are based upon 1 clinical trial in which 46 subjects with asthma aged 4 to 11 years 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.

Adult and Adolescent Subjects Aged 12 Years and Older The two 12-week, randomized, double-blind trials in 610 adult and adolescent subjects 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 trials 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. Adverse Reactions with VENTOLIN HFA with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects Adverse reactions reported by less than 3% of the adult and adolescent subjects receiving VENTOLIN HFA and by a greater proportion of subjects 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. Palpitations and dizziness have also been observed with VENTOLIN HFA.

Pediatric Subjects Aged 4 to 11 Years Results from the 2-week clinical trial in pediatric subjects with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations. Three trials have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in subjects between birth and 4 years of age. The results of these trials did not establish the efficacy of VENTOLIN HFA in this age group [see Use in Specific Populations 8- (8.4)].

Since the efficacy of VENTOLIN HFA has not been demonstrated in children between birth and 48 months of age, the safety of VENTOLIN HFA in this age group cannot be established. However, the safety profile observed in the pediatric population younger than 4 years was comparable to that observed in the older pediatric subjects and in adults and adolescents. Where adverse reaction incidence rates were greater in subjects younger than 4 years compared with older subjects, the higher incidence rates were noted in all treatment arms, including placebo.

These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the followi…

🔄 Drug Interactions ~1 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.

7.1Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as VENTOLIN HFA, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

7.2Non–Potassium-Sparing Diuretics The ECG changes and/or hypokalemia that may result from the administration of non‑potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of VENTOLIN HFA with non–potassium-sparing diuretics.

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 and 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.

👥 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 trials with 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. Women should be advised to contact their physicians if they become pregnant while taking VENTOLIN HFA. In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at exposures less than the maximum recommended human daily inhalation dose (MRHDID) for adults on a mg/m2 basis and in 10 of 108 (9.3%) fetuses at approximately 8 times the MRHDID.

Similar effects were not observed at approximately one eleventh of the MRHDID. 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 MRHDID.

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 MRHDID. Nonteratogenic Effects A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

8.2Labor and Delivery There are no well-controlled human trials that have investigated effects of VENTOLIN HFA on preterm labor or labor at term. Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA 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 aged 4 years and older have been established based upon two 12-week clinical trials in subjects aged 12 years and older with asthma and one 2-week clinical trial in subjects aged 4 to 11 years with asthma [see Adverse Reactions 6- (6.1), Clinical Studies 14- (14.1)]. The safety and effectiveness of VENTOLIN HFA in children younger than 4 years have not been established. Three trials have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in subjects younger than 4 years and the findings are described below.

Two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months 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 tri…

🆘 Overdosage 131 words ▾

10 OVERDOSAGE The expected signs and symptoms with overdosage of albuterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of VENTOLIN HFA Inhalation Aerosol.

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.

🧬 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 beta2-adrenergic receptors compared with isoproterenol. Although beta2-adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenoceptors are the predominant receptors in the heart, there are also beta2-adrenoceptors in the human heart comprising 10% to 50% of the total beta-adrenoceptors. The precise function of these receptors has not been established, but their presence raises the possibility that even selective beta2-agonists may have cardiac effects.

Activation of beta2-adrenergic receptors on airway smooth muscle leads to the activation of adenyl cyclase 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- (5.4)].

12.3Pharmacokinetics The systemic levels of albuterol are low after inhalation of recommended doses. A trial 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 (Tmax) was delayed after administration of VENTOLIN HFA (Tmax = 0.42 hours) as compared with CFC-propelled albuterol inhaler (Tmax = 0.17 hours).

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

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

16 HOW SUPPLIED/STORAGE AND HANDELING VENTOLIN® HFA (ALBUTEROL SULFATE) is supplied in the following dosage forms. NDC 51662-1267-1 VENTOLIN® HFA (ALBUTEROL SULFATE) 90mcg (1 Inhaler in Carton) NDC 51662-1267-9 VENTOLIN® HFA (ALBUTEROL SULFATE) 90mcg, 1 Inhaler HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms VENTOLIN HFA Inhalation Aerosol is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue strapcap: NDC 0173-0682-20 18-g canister containing 200 actuations NDC 0173-0682-24 8-g canister containing 60 actuations Each inhaler is sealed in a moisture-protective foil pouch with a desiccant that should be discarded when the pouch is opened.

Each inhaler is packaged with a Patient Information 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 actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first.

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 canister into fire or incinerator.

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.

SHAKE WELL BEFORE EACH SPRAY.

📋 Description 207 words ▾

11 DESCRIPTION The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(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 (C13H21NO3)2•H2SO4. 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 blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane).

It contains no other excipients. 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). 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. STRUCTURE

💬 Information for Patients ~3 min read ▾

PATIENT PACKAGE INFORMATION Patient Information VENTOLIN [vent′ o-lin] HFA (albuterol sulfate) Inhalation Aerosol Read the Patient Information that comes with VENTOLIN HFA Inhalation Aerosol before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is VENTOLIN HFA? VENTOLIN HFA is a prescription inhaled medicine used in people aged 4 years 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 younger than 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 “What are the ingredients in VENTOLIN HFA?” below for a complete list of ingredients. What should I tell my healthcare provider before using VENTOLIN HFA?

Tell your healthcare provider about all of your health conditions, including if you: • have heart problems. • have high blood pressure. • have seizures. • have thyroid problems. • have diabetes. • have low potassium levels in your blood. • are allergic to any of the ingredients in VENTOLIN HFA or any other medicines. See “What are the ingredients in VENTOLIN HFA?” below for a complete list of ingredients. • have any other medical conditions. • are pregnant or planning to become pregnant. It is not known if VENTOLIN HFA may harm your unborn baby. • are breastfeeding.

It is not known if the medicine in VENTOLIN HFA passes into your milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENTOLIN HFA and certain other medicines may interact with each other.

This may cause serious side effects. 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? Read the step-by-step instructions for using VENTOLIN HFA at the end of this Patient Information. • Do not use VENTOLIN HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. • Children should use VENTOLIN HFA with an adult’s help, as instructed by the child’s healthcare provider. • Use VENTOLIN HFA exactly as your healthcare provider tells you to use it.

Do not use VENTOLIN HFA more often than prescribed. • Do not increase your dose or take extra doses of VENTOLIN HFA without first talking to your healthcare provider. • 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 with VENTOLIN HFA? VENTOLIN HFA can 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…

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