Prescription medicine
Albuterol and ipratropium Brand names: Combivent
Albuterol and ipratropium (Combivent) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.0787 per mL (Ipratropium-albuterol 0.5-3(2.5) mg/3 mL) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $124.16 per gram (Combivent respimat 20-100 mcg).
- Generic listed
Check it at the source: the albuterol and ipratropium FDA label on DailyMed (effective June 22, 2026, Cipla USA Inc.); the NDA 20291 record on Drugs@FDA; every albuterol and ipratropium label on DailyMed.
Highlights of the record
FDA label of June 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIpratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
Forms and strengths
- 0.5 mg/3ml / 3 mg/3ml
- 0.5 mg/3ml / 2.5 mg/3ml
- 2.5 mg/3ml / 0.5 mg/3ml
Solution; spray (metered).
On the market
- Earliest approval on file
- October 24, 1996 Combivent, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first December 21, 2006; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 14 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 16, 2030 Combivent Respimat spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0787 per mL Ipratropium-albuterol 0.5-3(2.5) mg/3 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2015 0 Class I among all firms' recalls; latest March 26, 2024
- FAERS reports
- 4,316 through July 30, 2026
What is albuterol and ipratropium used for?
From the label: indications and usageIpratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
Conditions named in the indications of albuterol and ipratropium's FDA labels, with every medicine labeled for each:
From other albuterol and ipratropium labelsCOPD: INDICATIONS AND USAGE Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
FDA pharmacologic class: Anticholinergic and beta2-Adrenergic Agonist.
Source: FDA drug label (Ipratropium Bromide and Albuterol Sulfate), Cipla USA Inc., effective June 22, 2026 (SPL set 3c64255e-074c-41f8-a344-3686a0685020), via openFDA; the full label on DailyMed
What does the patient leaflet for albuterol and ipratropium say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using ipratropium bromide and albuterol sulfate inhalation solution?Do not get ipratropium bromide and albuterol sulfate inhalation solution in your eyes. Be careful not to spray ipratropium bromide and albuterol sulfate inhalation solution in your eyes while you are using your nebulizer. Ipratropium bromide and albuterol sulfate inhalation solution can cause the following short-term eye problems: Enlarged pupils Blurry vision Eye pain Ipratropium bromide and albuterol sulfate inhalation solution can cause a serious eye problem called narrow-angle glaucoma or worsen the narrow-angle glaucoma you already have.
From the patient leaflet: How should I store ipratropium bromide and albuterol sulfate inhalation solution?Store ipratropium bromide and albuterol sulfate inhalation solution at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light. Unit dose vials should remain stored in the protective foil pouch at all times. Once removed from the foil pouch, the individual vials should be used within one week. Discard if solution is not colorless. Safely discard ipratropium bromide and albuterol sulfate inhalation solution that is out-of-date or no longer needed. Keep ipratropium bromide and albuterol sulfate inhalation solution and all medicines out of the reach of children. General advice about Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. […]
Source: FDA drug label (Ipratropium Bromide and Albuterol Sulfate), Sun Pharmaceutical Industries, Inc., effective April 9, 2026 (SPL set 38f9a201-3954-4370-8e71-7ec2df88a1ff), via openFDA; the full label on DailyMed
Is there a generic for albuterol and ipratropium (Combivent)?
The FDA approved the first generic albuterol and ipratropium on December 21, 2006. 9 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists albuterol and ipratropium from 14 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Combivent Respimat spray, the last expiring on October 16, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2006 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for albuterol and ipratropium (Combivent)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0787 per mL (Ipratropium-albuterol 0.5-3(2.5) mg/3 mL), down 13% from $0.0903 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ipratropium-albuterol 0.5-3(2.5) mg/3 mL (generic)
- Combivent respimat 20-100 mcg (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ipratropium-albuterol 0.5-3(2.5) mg/3 mL | Generic | $0.0787 per mL | n/a | -13% |
| Combivent respimat 20-100 mcg | Brand | $124.16 per gram | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has albuterol and ipratropium been recalled?
The FDA's Enforcement Report lists 5 recalls naming albuterol and ipratropium since 2015: 0 Class I (the most serious), 4 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 26, 2024 | Class II | Cipla USA, Inc. | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. |
| April 13, 2022 | Class III | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| August 21, 2015 | Class II | Nephron Pharmaceuticals Corp. | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process |
| July 24, 2015 | Class II | Boehringer Ingelheim Roxane Inc | Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the albuterol and ipratropium label say about other medicines?
The albuterol and ipratropium label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | contraindications | CONTRAINDICATIONS Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives. |
Source: FDA drug label (Ipratropium Bromide and Albuterol Sulfate), Cipla USA Inc., effective June 22, 2026 (SPL set 3c64255e-074c-41f8-a344-3686a0685020), via openFDA; the full label on DailyMed
What do FAERS reports show for albuterol and ipratropium?
The FDA Adverse Event Reporting System holds 4,316 reports that list albuterol and ipratropium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 373 are coded as a death and 1,262 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as albuterol and ipratropium?
16 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as albuterol and ipratropium or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluticasone and salmeterol | COPD | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Budesonide and formoterol | COPD | 2 labelers | $17.26 per gram 160-4.5 | No current entry |
| Arformoterol | COPD | 15 labelers | $0.633 per mL 15 mcg/2 mL solution | No current entry |
| Formoterol | COPD | 11 labelers | $1.30 per mL 20 mcg/2 mL neb vial | No current entry |
| Fluticasone and vilanterol | COPD | none listed | $3.90 per unit 100-25 | No current entry |
| Budesonide and formoterol and glycopyrrolate | COPD | none listed | $61.41 per gram 160-9-4.8 mcg | No current entry |
| Fluticasone and umeclidinium and vilanterol | COPD | none listed | $11.12 per unit 100-62.5-25 | No current entry |
| Tiotropium | COPD | none listed | $126.08 per gram 1.25 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as albuterol and ipratropium
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to albuterol and ipratropium
- 16 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Albuterol and ipratropium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other