Quick answers
- What is Ipratropium bromide used for?
- The FDA-approved label (Atrovent HFA, Boehringer Ingelheim Pharmaceuticals, Inc., November 5, 2025) says: “ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ATROVENT HFA is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ipratropium bromide have a boxed warning?
- No. None of the 33 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ipratropium bromide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ipratropium bromide been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ipratropium bromide?
- 24 companies list prescription products of Ipratropium bromide in the FDA NDC Directory, including A-S Medication Solutions, Bausch & Lomb Incorporated and Hikma Pharmaceuticals USA Inc..
What Ipratropium bromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ATROVENT HFA is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
— FDA label: Atrovent HFA, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 5, 2025. Read the full label on DailyMed →
The FDA has 33 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 33 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Spray, metered · Solution · Spray · Aerosol · Aerosol, metered |
|---|---|
| Route | Nasal · Respiratory (inhalation) |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Atrovent HFA |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ipratropium bromide 0.5 mg/2.5 mL solution | Generic | $0.1035–$0.1135 per mL 16 packages, lowest to highest |
| ipratropium bromide 17 ug aerosol | Generic | $21.67 per gram |
| ipratropium bromide 17 ug aerosol, metered | Brand: Atrovent HFA | $22.76 per gram |
| ipratropium bromide 21 ug spray | Generic | $0.3811 per mL |
| ipratropium bromide 21 ug spray, metered | Generic | $0.3811 per mL |
| ipratropium bromide 42 ug spray | Generic | $0.7766 per mL |
| ipratropium bromide 42 ug spray, metered | Generic | $0.7766 per mL |
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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions3 products
- Bausch & Lomb Incorporated2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Advagen Pharma Ltd2 products
- Cardinal Health 107, LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- NorthStar Rx LLC2 products
- Oceanside Pharmaceuticals2 products
- Bryant Ranch Prepack2 products
- Amneal Pharmaceuticals NY LLC2 products
- Apotex Corp.2 products
- Sun Pharmaceutical Industries, Inc.1 product
- Redpharm Drug1 product
- Armstrong Pharmaceuticals, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- Nephron Pharmaceuticals Corporation1 product
- Sportpharm LLC1 product
- Chartwell RX, LLC1 product
- Boehringer Ingelheim Pharmaceuticals, Inc.1 product
- Ritedose Pharmaceuticals, LLC1 product
- American Health Packaging1 product
- NuCare Pharmaceuticals, Inc.1 product
- Aurobindo Pharma Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021527 ATROVENT HFA | Boehringer Ingelheim | November 17, 2004 | 12, latest December 30, 2024 2024: Labeling · 2020: Labeling · 2016: Labeling |
Generic approvals (17)
- ANDA075693Ritedose Corp · January 26, 2001
- ANDA075562Nephron · September 27, 2001
- ANDA076025Bausch · March 31, 2003
- ANDA076103Bausch · March 31, 2003
- ANDA076155Apotex Inc · April 18, 2003
- ANDA076156Apotex Inc · April 18, 2003
- ANDA076598Hikma · November 5, 2003
- ANDA076664Hikma · November 5, 2003
- ANDA206543Luoxin Aurovitas · October 27, 2016
- ANDA207903Sun Pharm · January 3, 2017
- ANDA215104Amneal · August 16, 2022
- ANDA215105Amneal · August 16, 2022
- ANDA219221Rubicon Research · November 15, 2024
- ANDA219222Rubicon Research · January 14, 2025
- ANDA217886Lupin · January 27, 2025
- ANDA217912Lupin · February 7, 2025
- ANDA217953Armstrong Pharms · February 23, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1040-2022
cGMP deviations: Temperature abuse
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Atrovent HFA, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →