Prescription medicine
Zafirlukast First approved as Accolate
Zafirlukast (Accolate) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.623 per zafirlukast 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the zafirlukast FDA label on DailyMed (effective December 1, 2023, Aurobindo Pharma Limited); the NDA 20547 record on Drugs@FDA; every zafirlukast label on DailyMed.
Highlights of the record
FDA label of December 1, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
Forms and strengths
- 10 mg
- 20 mg
Film-coated tablet; coated tablet.
On the market
- Earliest approval on file
- September 26, 1996 Accolate, Strides Pharma Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first November 18, 2010; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.623 per tablet Zafirlukast 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 881 through July 30, 2026
What is zafirlukast used for?
From the label: indications and usageZafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
Conditions named in the indications of zafirlukast's FDA labels, with every medicine labeled for each:
From other zafirlukast labelsAsthma: INDICATIONS AND USAGE Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
FDA pharmacologic class: Leukotriene Receptor Antagonist.
Source: FDA drug label (Zafirlukast), Aurobindo Pharma Limited, effective December 1, 2023 (SPL set 8bdb47c5-9d19-4d59-94c8-62c117525e7f), via openFDA; the full label on DailyMed
Is there a generic for zafirlukast (Accolate)?
The FDA approved the first generic zafirlukast on November 18, 2010. 4 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 zafirlukast from 5 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.
- 1996 earliest approval on file
- 2010 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for zafirlukast (Accolate)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.623 per Zafirlukast 20 mg tablet, down 8% from $0.678 on October 8, 2025. 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.
- Zafirlukast 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Zafirlukast 10 mg tablet | Generic | $0.517 per tablet | $15.51 | -16% |
| Zafirlukast 20 mg tablet | Generic | $0.623 per tablet | $18.70 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the zafirlukast label say about other medicines?
The zafirlukast label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name zafirlukast. 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 |
|---|---|---|
| Aspirin | drug interactions | Coadministration of zafirlukast (40 mg/day) with aspirin (650 mg four times daily) resulted in mean increased plasma levels of zafirlukast by approximately 45%. |
| Carbamazepine | drug interactions | No formal drug-drug interaction studies with zafirlukast and other drugs known to be metabolized by the cytochrome P450 2C9 isoenzyme (e.g., tolbutamide, phenytoin, carbamazepine) have been conducted; however, care should be exercised when zafirlukast is coadministered with these drugs. |
| Erythromycin | drug interactions | In a drug interaction study in 11 asthmatic patients, coadministration of a single dose of zafirlukast (40 mg) with erythromycin (500 mg three times daily for 5 days) to steady-state resulted in decreased mean plasma levels of zafirlukast by approximately 40% due to a decrease in zafirlukast bioavailability. |
| Fluconazole | drug interactions | Coadministration of zafirlukast with fluconazole, a moderate CYP2C9 inhibitor, resulted in increased plasma levels of zafirlukast, by approximately 58% (90% CI:28, 95). |
| Itraconazole | drug interactions | Coadministration of zafirlukast with itraconazole, a strong CYP3A4 inhibitor, caused no change in plasma levels of zafirlukast. |
| Phenytoin | drug interactions | No formal drug-drug interaction studies with zafirlukast and other drugs known to be metabolized by the cytochrome P450 2C9 isoenzyme (e.g., tolbutamide, phenytoin, carbamazepine) have been conducted; however, care should be exercised when zafirlukast is coadministered with these drugs. |
| Theophylline | drug interactions | Coadministration of zafirlukast (20 mg/day) or placebo at steady-state with a single dose of sustained release theophylline preparation (16 mg/kg) in 16 healthy boys and girls (6 through 11 years of age) resulted in no significant differences in the pharmacokinetic parameters of theophylline. |
| Warfarin | drug interactions | Drug Interactions: In a drug interaction study in 16 healthy male volunteers, coadministration of multiple doses of zafirlukast (160 mg/day) to steady-state with a single 25 mg dose of warfarin resulted in a significant increase in the mean AUC (+ 63%) and half-life (+36%) of S-warfarin. |
Source: FDA drug label (Zafirlukast), Aurobindo Pharma Limited, effective December 1, 2023 (SPL set 8bdb47c5-9d19-4d59-94c8-62c117525e7f), via openFDA; the full label on DailyMed
What do FAERS reports show for zafirlukast?
The FDA Adverse Event Reporting System holds 881 reports that list zafirlukast among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 210 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 zafirlukast?
9 other medicines are given the same way (oral) and in the same FDA class as zafirlukast or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 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 (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Montelukast | Asthma | 36 labelers | $0.0419 per tablet 10 mg tablet | A presentation being discontinued |
| Dexamethasone | Asthma | 41 labelers | $0.193 per tablet 4 mg tablet | In shortage |
| Theophylline | Asthma | 26 labelers | $0.330 per tablet 300 mg tablet | No current entry |
| Albuterol | Asthma | 14 labelers | $0.288 per tablet 2 mg tablet | Resolved |
| Budesonide | Asthma | 14 labelers | $0.498 per capsule 3 mg capsule | No current entry |
| Zileuton | Asthma | 5 labelers | $2.05 per tablet 600 mg tablet | No current entry |
| Ephedrine | Asthma | none listed | n/a | No current entry |
| Cromolyn | Asthma | 3 labelers | $0.349 per mL 100 mg/5 mL oral conc | Listed; available |
Every medicine labeled for the same conditions as zafirlukast
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does zafirlukast compare with medicines for the same use?
1 side-by-side page set zafirlukast beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to zafirlukast
- 9 medicines for the same use
- Other leukotriene receptor antagonists
- the pharmacologic class, with prices and generics
- Zafirlukast side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other