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Brand-name prescription medicine

Ventolin HFA

Generic name: Albuterol sulfate

FDA application holder: Glaxosmithkline

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Ventolin HFA?
Ventolin HFA is a brand name of Albuterol sulfate, a prescription medicine. The FDA NDC Directory lists 8 Ventolin HFA products in 1 strength and form.
Who makes Ventolin HFA?
Glaxosmithkline holds the FDA application for Ventolin HFA (NDA020983, approved April 19, 2001). 4 other companies (repackagers or distributors) also list Ventolin HFA products.
Is there a generic or store brand of Ventolin HFA?
Yes. The FDA NDC Directory lists 31 other products with the same active ingredients, strength and form as a Ventolin HFA product, 27 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Ventolin HFA?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Ventolin HFA strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Ventolin HFA been recalled?
FDA enforcement reports list 4 recalls of Ventolin HFA products; the newest started May 16, 2017. A recall usually concerns specific lots, not every product.

What Ventolin HFA is

Each Ventolin HFA product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Albuterol sulfate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
albuterol sulfate 90 ug
aerosol, metered (respiratory (inhalation))
Ventolin HFA 31 products, 17 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Albuterol sulfate →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Ventolin HFA products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA020983GlaxosmithklineApril 19, 20018

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ventolin HFA, by strength and form
Strength and formGeneric or brandPharmacies pay
albuterol sulfate 90 ug
aerosol, metered
Brand: Ventolin HFA $2.72–$3.03 per gram
2 packages, lowest to highest
Generic of the same strength and form: $1.52–$2.08 per gram

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Ventolin HFA

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Ventolin HFA products.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. May 16, 2017 · Class II · Ongoing · D-0793-2017

    Defective Delivery System: Elevated number of units with out of specification results for leak rate

    Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20. — GlaxoSmithKline, LLC

  2. March 22, 2017 · Class II · Ongoing · D-0626-2017

    Defective Delivery System: Elevated number of units with out of specification results for leak rate.

    Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20. — GlaxoSmithKline, LLC

  3. December 3, 2015 · Class II · Terminated · D-0519-2016

    Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

    Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 — GlaxoSmithKline, LLC

  4. July 26, 2012 · Class II · Terminated · D-1666-2012

    Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

    Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Tri — GlaxoSmithKline Inc

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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