Quick answers
- What is Zafirlukast used for?
- The FDA-approved label (Zafirlukast, Strides Pharma Science Limited, March 16, 2026) says: “Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Zafirlukast have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Zafirlukast?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Zafirlukast been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Zafirlukast?
- 7 companies list prescription products of Zafirlukast in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Dr. Reddys Laboratories Limited and Strides Pharma Science Limited.
What Zafirlukast is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
— FDA label: Zafirlukast, Strides Pharma Science Limited, effective March 16, 2026. Read the full label on DailyMed →
The FDA has 7 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 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 12 in the FDA NDC Directory |
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 |
|---|---|---|
| zafirlukast 10 mg tablet, coated | Generic | $0.5416 per tablet |
| zafirlukast 10 mg tablet, film coated | Generic | $0.5416 per tablet |
| zafirlukast 20 mg tablet, coated | Generic | $0.6244 per tablet |
| zafirlukast 20 mg tablet, film coated | Generic | $0.6244 per tablet |
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.
- Camber Pharmaceuticals, Inc.2 products
- Dr. Reddys Laboratories Limited2 products
- Strides Pharma Science Limited2 products
- Aurobindo Pharma Limited2 products
- AvKARE2 products
- Bryant Ranch Prepack1 product
- American Health Packaging1 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 |
|---|---|---|---|
| NDA020547 ACCOLATE | Strides Pharma Intl | September 26, 1996 | 27, latest March 29, 2016 2016: Manufacturing (CMC) · 2013: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (3)
- ANDA090372DR Reddys Labs Ltd · November 18, 2010
- ANDA212475Annora Pharma · September 10, 2020
- ANDA213163Aurobindo Pharma · November 27, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 199655, 313758 |
|---|---|
| SPL set ID of the quoted label | baba507f-6557-4551-815c-9ab6606e4ee1 |
| FDA labels (SPL) | 7 |
| FDA applications | NDA020547, 3 ANDA |
| Active ingredients (FDA) | ZAFIRLUKAST |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zafirlukast, Strides Pharma Science Limited, effective March 16, 2026; 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 →