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Albuterol 90 ug Aerosol, Metered — NDC 69097-0021-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Albuterol 90 ug Aerosol, Metered — NDC 69097-021-60 (Billing 69097-0021-60)

by Cipla USA Inc. · 1 INHALER in 1 CARTON / 200 AEROSOL, METERED in 1 INHALER

This is a package of Albuterol 90 ug Aerosol, Metered from Cipla USA Inc., marketed since Apr 2026 and currently FDA-listed; retail pharmacies pay about $1.83 per g (NADAC). It is this product's only package size.

NDC 69097-0021-60
🏷️ FDA NDC (as labeled) 69097-021-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 69097-021-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69097 labeler · 021 product · 60 package
Package marketed since
Apr 22, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6909702160 3
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) 69097-021-60
Product NDC 69097-021
11-digit billing NDC 69097002160
NCPDP billing unit GM — per gram (weight)
RxCUI 2123076
UNII 021SEF3731
Application # ANDA219409
SPL Set ID fd0389e0-3713-42e0-8ef2-3bb97676fded
Established class (EPC) beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-22
Route RESPIRATORY (INHALATION)
Dosage form AEROSOL, METERED
Substance ALBUTEROL SULFATE
TE code (Orange Book) AB3 · RLD · RS
Quick answers
  • RxCUI (RxNorm): 2123076
Why two NDCs? The FDA registers this code as 69097-021-60 — 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 → 69097-0021-60. 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

📖 What it is MedlinePlus · NLM

Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 ye...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Albuterol opens up your airways when the muscles around them tighten (bronchospasm), as in asthma. Inhalers and powders are also used before exercise to prevent exercise-induced br...
  • It is breathed in through your mouth. The usual pattern for bronchospasm is a couple of puffs every 4 to 6 hours, and before exercise it is used 15 to 30 minutes ahead. Some inhale...
  • The most common are throat irritation, cough, upper respiratory irritation, viral respiratory infections and muscle or bone aches. These are usually manageable. Call me or your doc...
  • Get help right away if your breathing gets worse after a dose, or if you have hives, swelling of the face or throat, or chest pain or a racing heartbeat. Also call your doctor if y...
📖 Read our full Albuterol guide →
2
Nutrient depletion considerations

Albuterol 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 gPer package
Retail pharmacies payNADAC · weekly $1.826 —
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.
NADAC price history (per g) — tap or hover for the price & month
Aug 2026 Sep 2026 $1.826 $1.819
Flat over the last 2 months.
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
69097-0021-60 You're viewing this Main listing 1 INHALER in 1 CARTON / 200 AEROSOL, METERED in 1 INHALER 2026-04-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuterol Sulfate HFA 90 ug 00093-3174-31 Teva 1 inhaler $1.540 AB2 Availability likely save 16%
Albuterol Sulfate 90 ug 17270-0740-00 Armstrong 1 inhaler $1.540 AB2 Availability likely save 16%
albuterol sulfate 90 ug 45802-0088-01 Padagis 1 inhaler $1.540 AB2 Availability likely save 16%
Albuterol sulfate 90 ug 68180-0963-01 Lupin 1 canister $1.540 AB2 Availability likely save 16%
Albuterol Sulfate HFA 90 ug 66993-0019-68 Prasco 1 inhaler $1.825 AB3 Availability likely —
Albuterol 90 ugthis 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 +16%
Albuterol Sulfate 90 ug 00054-0742-87 Hikma 1 canister $2.120 AB1 Availability likely +16%
Albuterol Sulfate 90 ug 60687-0662-91 American 1 canister $2.120 AB1 Availability likely +16%
Albuterol Sulfate 90 ug 69097-0142-60 Cipla 1 canister $2.120 AB1 Availability likely +16%
Ventolin Hfa 90 ug 00173-0682-20 GlaxoSmithKline 1 inhaler $3.035 AB3 Availability likely +66%
ProAir Digihaler 90 ug 59310-0117-20 Teva 1 inhaler $86.326 — FDA listed +4629%
Ventolin Hfa 90 ug 50090-1159-00 A-S 1 inhaler — AB3 FDA listed —
albuterol sulfate HFA 90 ug 50090-4137-00 A-S 1 inhaler — AB3 FDA listed —
Ventolin Hfa 90 ug 63187-0026-08 Proficient 60 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 68071-1670-02 NuCare 200 aerosols — AB3 FDA listed —
Albuterol Sulate HFA 90 ug 68071-4777-02 NuCare 200 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 70518-1081-00 REMEDYREPACK 200 aerosols — AB3 FDA listed —
Albuterol Sulate HFA 90 ug 70518-2072-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
Albuterol Sulfate HFA 90 ug 80425-0359-01 Advanced 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 51662-1513-01 HF 1 inhaler — AB2 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 70518-1237-00 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 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 —
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 —
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 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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
First FDA approval
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2026. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 22, 2026 AB3 TE-rated RLD RS ⏳ ~0.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity CGT
2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
CGTFDA-granted marketing exclusivityDec 19, 2026
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

💡 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.

Manufacturer & labeler

LabelerCipla USA Inc.
Application holderCIPLA LTD
FDA applicationANDA219409 (ANDA)
Labeler code69097
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio222 products on file

More NDCs from Cipla USA Inc. labeler code 69097

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 111 words ▾

1 INDICATIONS AND USAGE Albuterol sulfate inhalation aerosol is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 )

1.1Bronchospasm Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease.

1.2Exercise-Induced Bronchospasm Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2 ) Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient.

( 2.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. ( 2.2 ) Priming information: Prime albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol, 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 )

2.1Recommended Dosage for Bronchospasm (Acute Episodes or Symptoms Associated with Bronchospasm) Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 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.

2.2Recommended Dosage for Prevention of Exercise-Induced Bronchospasm Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise.

2.3Administration Information Albuterol sulfate inhalation aerosol should be administered by the orally inhaled route only. Priming Priming albuterol sulfate inhalation aerosol is essential to ensure appropriate albuterol content in each actuation. Prime albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. 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 59 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation aerosol: 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece per actuation. White plastic inhaler with a blue cap and fitted with a counter containing a pressurized metered-dose aerosol canister containing 200 metered inhalations. Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base) per actuation. ( 3 )

⛔ Contraindications 39 words ▾

4 CONTRAINDICATIONS Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.6 ), Description ( 11 )] . Hypersensitivity to any ingredient. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue albuterol sulfate inhalation aerosol immediately and institute alternative therapy. ( 5.1 ) Need for more doses of albuterol sulfate inhalation aerosol than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.

( 5.2 ) Albuterol sulfate inhalation aerosol is not a substitute for corticosteroids. ( 5.3 ) Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders.

( 5.4 , 5.7 ) Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) Immediate hypersensitivity reactions may occur.

Discontinue albuterol sulfate inhalation aerosol immediately. ( 5.6 ) Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 )

5.1Paradoxical Bronchospasm Albuterol sulfate inhalation aerosol can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with albuterol sulfate inhalation aerosol, 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 albuterol sulfate inhalation aerosol 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 Albuterol sulfate inhalation aerosol, 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, albuterol sulfate inhalation aerosol 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, albuterol sulfate inhalation aerosol, 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.

5.6Hypersensitivity Reactions, including Anaphylaxis Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of albuterol sulfate inhalation aerosol [see Contraindications ( 4 )] .

5.7Coexisting Conditions Albuterol sulfate inhalation aerosol, 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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )] Cardiovascular effects [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions, including anaphylaxis [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.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 albuterol sulfate in 248 subjects treated with albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. Overall, the incidence and nature of the adverse reactions reported for albuterol sulfate inhalation aerosol 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% in the group treated with albuterol sulfate inhalation aerosol and more frequently in the group treated with albuterol sulfate inhalation aerosol than in the HFA-134a placebo inhaler group.

Table 1. Adverse Reactions with Albuterol Sulfate Inhalation Aerosol with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects Adverse Reaction Percent of Subjects Albuterol Sulfate Inhalation Aerosol (n = 202) % CFC 11/12-Propelled Albuterol Inhaler (n = 207) % Placebo HFA-134a (n = 201) % Ear, nose, and throat Throat irritation Upper respiratory inflammation 10 5 6 5 7 2 Lower respiratory Viral respiratory infections Cough 7 5 4 2 4 2 Musculoskeletal Musculoskeletal pain 5 5 4 Adverse reactions reported by <3% of the adult and adolescent subjects receiving albuterol sulfate inhalation aerosol and by a greater proportion of subjects receiving albuterol sulfate inhalation aerosol than receiving HFA-134a placebo inhaler and that have the potential to be related to albuterol sulfate inhalation aerosol include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles.

Palpitations and dizziness have also been observed with albuterol sulfate inhalation aerosol. 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… [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: Use with caution.

May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.1 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.

( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ( 7.3 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution.

May potentiate effect of albuterol on vascular system. ( 7.4 )

7.1Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as albuterol sulfate inhalation aerosol, 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 albuterol sulfate inhalation aerosol 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 Albuterol sulfate inhalation aerosol 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 Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more information, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Risk Summary There are no randomized clinical studies of use of albuterol sulfate during pregnancy.

Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are, however, clinical considerations in pregnant women with asthma. (See Clinical Considerations.) Administration of albuterol sulfate to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (MRHDID).

(See Data.) The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.

Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. Labor or Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of albuterol sulfate inhalation aerosol during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Albuterol sulfate inhalation aerosol has not been approved for the management of pre-term labor.

Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiological studies and case reports have not consistently demonstrated an association with use of albuterol sulfate inhalation aerosol during pregnancy and major birth defects, specific birth defects, or miscarriage. The available studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact.

Animal Data: In a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta 2 -agonist. In a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m 2 basis at a maternal dose of 50 mg/kg).

In a study in pregnant rabbits, an albuterol/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHDID on a mg/m 2 basis. 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.

8.2Lactation Risk Summary There are no available data on the pre… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 135 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 albuterol sulfate inhalation aerosol.

Treatment consists of discontinuation of albuterol sulfate inhalation aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol sulfate inhalation aerosol.

🧬 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. Although beta 2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -adrenoceptors are the predominant receptors in the heart, there are also beta 2 -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 beta 2 -agonists may have cardiac effects.

Activation of beta 2 -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 ( 5.4 )] .

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 (T max ) was delayed after administration of albuterol sulfate inhalation aerosol (T max = 0.42 hours) as compared with CFC-propelled albuterol inhaler (T max = 0.17 hours).

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

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

16 HOW SUPPLIED/STORAGE AND HANDLING Albuterol sulfate inhalation aerosol is supplied in the following boxes of 1 as a pressurized aluminum canister and supplied with a white plastic actuator with a blue cap fitted with a counter: NDC 69097-021-60 18-g canister containing 200 actuations Each inhaler is packaged with a Patient Information leaflet. The white actuator supplied with albuterol sulfate inhalation aerosol should not be used with any other product canisters, and actuators from other products should not be used with an albuterol sulfate inhalation aerosol canister.

Counter Albuterol sulfate inhalation aerosol has a counter attached to the actuator. The counter starts at 200 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 0, even though the canister is not completely empty and will continue to operate.

The inhaler should be discarded when the counter reads 0. 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. Storage 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.

📋 Description ~1 min read ▾

11 DESCRIPTION The active component of albuterol sulfate inhalation aerosol 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 freely soluble in water and very slightly soluble in ethanol.

The World Health Organization recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation aerosol is a white plastic inhaler with a blue cap fitted with a counter containing a pressurized metered-dose aerosol canister. 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 albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. image description

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Frequency of Use Inform patients that the action of albuterol sulfate inhalation aerosol should last up to 4 to 6 hours. Do not use albuterol sulfate inhalation aerosol more frequently than recommended.

Instruct patients not to increase the dose or frequency of doses of albuterol sulfate inhalation aerosol without consulting the physician. Instruct patients to seek medical attention immediately if treatment with albuterol sulfate inhalation aerosol becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual. Priming Instruct patients to prime albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes. Cleaning To ensure proper dosing and to prevent actuator orifice blockage, instruct patients to wash the actuator with warm water and let it air-dry completely at least once a week.

Inform patients that detailed cleaning instructions are included in the Patient Information leaflet. Paradoxical Bronchospasm Inform patients that albuterol sulfate inhalation aerosol can produce paradoxical bronchospasm. Instruct them to discontinue albuterol sulfate inhalation aerosol if paradoxical bronchospasm occurs [see Warnings and Precautions ( 5.1 )] .

Concomitant Drug Use Advise patients that while they are using albuterol sulfate inhalation aerosol, other inhaled drugs and asthma medications should be taken only as directed by the physician. Common Adverse Effects Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness. Pregnancy Exposure Registry Inform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications, including albuterol sulfate inhalation aerosol, during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/asthma [see Use in Specific Populations ( 8.1 )] .

Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Fall River, MA 02720, USA. Manufactured for: Cipla USA, Inc.

10 Independence Boulevard, Suite 300 Warren, NJ07059 Revised: 6/2025

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

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

Subjects taking the HFA-134a placebo inhaler also took albuterol sulfate inhalation aerosol for asthma symptom relief on an as-needed basis. Some subjects 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 albuterol sulfate inhalation aerosol 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 trial, albuterol sulfate inhalation aerosol (101 subjects) was compared with CFC 11/12-propelled albuterol (99 subjects) and an HFA-134a placebo inhaler (97 subjects) in adolescent and adult subjects aged 12 to 76 years 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 albuterol sulfate inhalation aerosol 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 albuterol sulfate inhalation aerosol, 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 subjects, duration of effect was as long as 6 hours. The second 12-week randomized, double-blind trial was conducted to evaluate the efficacy and safety of switching subjects from CFC 11/12-propelled albuterol to albuterol sulfate inhalation aerosol.

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

The switching from CFC 11/12-propelled albuterol inhaler to albuterol sulfate inhalation aerosol did not reveal any clinically significant changes in the efficacy profile. In the 2 adult trials, the efficacy results from albuterol sulfate inhalation aerosol 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 Subjects Aged 4 to 11 Years The efficacy of albuterol sulfate inhalation aerosol was evaluated in one 2-week, randomized, double-blind, placebo-controlled trial in 135 pediatric subjects aged 4 to 11 years with mild to moderate asthma. In this trial, subjects received albuterol sulfate inhalation aerosol, CFC 11/12-propelled alb… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 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 mg/kg (approximately 15 and 6 times the MRHDID for adults and children, respectively, 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 1,900 and 740 times the MRHDID for adults and children, respectively, 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 250 and 100 times the MRHDID for adults and children, respectively, 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.

Fertility and reproductive performance in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 380 times the MRHDID for adults on a mg/m 2 basis).

13.2Animal Toxicology and/or Pharmacology Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain. Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently.

The clinical relevance of these findings is unknown.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Albuterol Sulfate (al bue’ ter ol sul’ fate) Inhalation Aerosol for oral inhalation use What is Albuterol Sulfate Inhalation Aerosol? Albuterol Sulfate Inhalation Aerosol 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 Albuterol Sulfate Inhalation Aerosol is safe and effective in children younger than 4 years of age.

Do not use Albuterol Sulfate Inhalation Aerosol : if you are allergic to albuterol sulfate propionate or any of the ingredients in Albuterol Sulfate Inhalation Aerosol. See the end of this Patient Information for a complete list of ingredients in Albuterol Sulfate Inhalation Aerosol. Before using Albuterol Sulfate Inhalation Aerosol , tell your healthcare provider about all of your medical 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 pregnant or plan to become pregnant.

It is not known if albuterol may harm your unborn baby. o Pregnancy Registry. There is a pregnancy registry for women with asthma who receive asthma medications, including Albuterol Sulfate Inhalation Aerosol, while pregnant. The purpose of the registry is to collect information about the health of you and your baby.

You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/asthma. are breastfeeding. It is not known if the medicine in Albuterol Sulfate Inhalation Aerosol 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.

Albuterol Sulfate Inhalation Aerosol 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 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 Albuterol Sulfate Inhalation Aerosol ? Read the step-by-step instructions for using Albuterol Sulfate Inhalation Aerosol at the end of this Patient Information.

Do not use Albuterol Sulfate Inhalation Aerosol unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Children should use Albuterol Sulfate Inhalation Aerosol with an adult’s help, as instructed by the child’s healthcare provider. Use Albuterol Sulfate Inhalation Aerosol exactly as your healthcare provider tells you to use it.

Do not use Albuterol Sulfate Inhalation Aerosol more often than prescribed. Do not increase your dose or take extra doses of Albuterol Sulfate Inhalation Aerosol without first talking to your healthcare provider. Each dose of Albuterol Sulfate Inhalation Aerosol should last up to 4 hours to 6 hours.

Get medical help right away if Albuterol Sulfate Inhalation Aerosol 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 Albuterol Sulfate Inhalation Aerosol, 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 Albuterol Sulfate Inhalation Aerosol ?

Albuterol Sulfate Inhalation Aerosol can cause serious side effects, including: worsening t… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Albuterol Sulfate (al bue’ ter ol sul’ fate) Inhalation Aerosol for oral inhalation use Your Albuterol Sulfate Inhalation Aerosol inhaler The metal canister holds the medicine. See Figure A. The plastic actuator has a counter to show how many sprays of medicine you have left.

The number shows through a window in the front of the white plastic actuator. See Figure A. The counter starts at 200.

The number will count down by 20 units each time the inhaler has been sprayed 20 times. The counter will stop counting at 0 . Do not try to change the numbers or take the counter off the actuator .

The counter cannot be reset, and it is permanently attached into the actuator. The white plastic actuator sprays the medicine from the metal canister. The plastic actuator has a blue protective cap that covers the mouthpiece.

See Figure A. Keep the protective cap on the mouthpiece when the metal canister is not in use. Do not use the plastic actuator with a canister of medicine from any other inhaler.

Do not use Albuterol Sulfate Inhalation Aerosol metal canister with an actuator from any other inhaler. Before using your Albuterol Sulfate Inhalation Aerosol inhaler The inhaler should be at room temperature before you use it. If your child needs to use Albuterol Sulfate Inhalation Aerosol, watch your child closely to make sure your child uses the inhaler correctly.

Your healthcare provider will show you how your child should use Albuterol Sulfate Inhalation Aerosol. Priming your Albuterol Sulfate Inhalation Aerosol inhaler Before you use Albuterol Sulfate Inhalation Aerosol for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it. To take the cap off the mouthpiece, squeeze the sides of the cap and pull it straight out.

See Figure B. Shake the inhaler well. Spray the inhaler 1 time into the air away from your face.

Avoid spraying in eyes. See Figure C. Shake and spray the inhaler like this 3 more times to finish priming it.

The counter should now read 200 . See Figure D. You must prime your inhaler again if you have not used it in more than 14 days or if you have dropped it.

To take the cap off the mouthpiece, squeeze the sides of the cap and pull it straight out. Shake and spray the inhaler 4 times into the air away from your face. How to use your Albuterol Sulfate Inhalation Aerosol inhaler Follow these steps every time you use Albuterol Sulfate Inhalation Aerosol.

Step 1. Make sure the metal canister fits firmly in the plastic actuator. The counter should show through the window in the actuator.

To take the cap off the mouthpiece, squeeze the sides of the cap and pull it straight out. Look inside the mouthpiece for foreign objects and take out any you see. Step 2.

Hold the inhaler with the mouthpiece down and shake it well . See Figure E. Step 3.

Breathe out through your mouth and push as much air from your lungs as you can. See Figure F. Step 4.

Put the mouthpiece in your mouth and close your lips around it. Push the top of the metal canister firmly all the way down while you breathe in deeply and slowly through your mouth. See Figure G.

Step 5. After the spray comes out, take your finger off the metal canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

Step 6. Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly as long as you can.

If your healthcare provider has told you to use more sprays , wait 1 minute and shake the inhaler again. Repeat Step 2 through Step 6. Put the cap back on the mouthpiece after you finish using the inhaler.

Make sure it snaps firmly into place. Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler Clean your inhaler at least 1 time each week. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray.

See Figure H. Step 7. Take the canister out of the plastic actua… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 66 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 200 Metered Inhalations NDC 69097-021-60 Rx Only Albuterol Sulfate Inhalation Aerosol 90 mcg per actuation For oral inhalation with Albuterol Sulfate Inhalation Aerosol actuator only. Contents: Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a(1,1,1,2-tetrafluoroethane). Each actuation delivers 108 mcg of albuterol sulfate equivalent to 90 mcg albuterol base from the mouthpiece.

Cipla Net Wt. 18 g carton-label1

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

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

Medicare Part D (outpatient prescription) spending for Albuterol Sulfate HFA (matched by generic name) — the program that covers self-administered drugs. 10 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 HFA. CMS lists 5 products for this generic; we show the highest-spend one. 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
$136.02M
Claims incl. refills
5M
Beneficiaries
3.3M
Spend / beneficiary
$40.82
Spend / claim
$27.21
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 (this brand).

Top reported reactions

Dyspnoea28,534
Asthma15,240
Cough13,444
Fatigue11,519
Headache10,825
Device Delivery System Issue10,772
Pneumonia10,737

Age at onset

Neonate151
Infant171
Child1,579
Adolescent1,228
Adult20,446
Elderly14,102

Reporter sex

202,185 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization59,752
Death13,425
Life-threatening7,163
Disabling5,134
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25,437 0
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.
← 69097-0008-22 · Cipla 69097-0027-50 · Cipla →
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.