Quick answers
- What is Montelukast used for?
- The FDA-approved label (Singulair, Organon LLC, April 30, 2025) says: “SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Relief of symptoms of allergic rhinitis (AR) …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Montelukast have a boxed warning?
- Yes. The FDA label for Singulair has a boxed warning (“WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Montelukast?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 17, 2025). Ask your pharmacist about alternatives.
- Has Montelukast been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started October 13, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Montelukast?
- 34 companies list prescription products of Montelukast in the FDA NDC Directory, including Proficient Rx LP, A-S Medication Solutions and NuCare Pharmaceuticals, Inc..
What Montelukast is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Relief of symptoms of allergic rhinitis (AR) …
— FDA label: Singulair, Organon LLC, effective April 30, 2025. Read the full label on DailyMed →
The FDA has 62 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.
This label has a boxed warning. Its heading: WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
. Read it on the full label →
47 of 62 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, chewable · Tablet, film coated · Tablet · Granule · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 93 in the FDA NDC Directory |
| Brand names | Singulair |
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 |
|---|---|---|
| montelukast 4 mg tablet, chewable | Generic | $0.0784 per tablet |
| montelukast 5 mg tablet, chewable | Generic | $0.0723 per tablet |
| montelukast sodium 10 mg tablet | Generic | $0.0432 per tablet |
| montelukast sodium 10 mg tablet, coated | Generic | $0.0432 per tablet |
| montelukast sodium 10 mg tablet, film coated | Generic | $0.0432 per tablet |
| montelukast sodium 10 mg tablet, film coated | Brand: Singulair | $9.23 per tablet |
| montelukast sodium 4 mg granule | Generic | $0.7796 per unit |
| montelukast sodium 4 mg tablet, chewable | Generic | $0.0784 per tablet |
| montelukast sodium 4 mg/500 mg granule | Generic | $0.7796 per unit |
| montelukast sodium 5 mg tablet, chewable | Generic | $0.0723 per tablet |
| montelukast sodium 5 mg tablet, chewable | Brand: Singulair | $9.27 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and 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.
- Proficient Rx LP11 products
- A-S Medication Solutions6 products
- NuCare Pharmaceuticals, Inc.5 products
- Organon LLC4 products
- Torrent Pharmaceuticals Limited4 products
- Aurobindo Pharma Limited4 products
- Preferred Pharmaceuticals Inc.4 products
- Rising Pharma Holdings, Inc.4 products
- Ajanta Pharma USA Inc.4 products
- Bryant Ranch Prepack4 products
- Dr. Reddy's Laboratories Limited3 products
- Amneal Pharmaceuticals LLC3 products
- Macleods Pharmaceuticals Limited3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- AvPAK3 products
- Camber Pharmaceuticals, Inc.3 products
- Chartwell RX, LLC2 products
- Remedyrepack Inc.2 products
- AvKARE2 products
- Lannett Company, Inc.2 products
- Direct_Rx2 products
- XLCare Pharmaceuticals, Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- BluePoint Laboratories1 product
- Coupler LLC1 product
- Sandoz Inc1 product
- Westminster Pharmaceuticals, LLC1 product
- Quallent Pharmaceuticals Health LLC1 product
- Accord Healthcare Inc.1 product
- Cardinal Health 107, LLC1 product
- Redpharm Drug1 product
- Major Pharmaceuticals1 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 |
|---|---|---|---|
| NDA020829 SINGULAIR | Organon | February 20, 1998 | 56, latest February 22, 2021 2021: Labeling · 2020: Labeling · 2019: Labeling |
| NDA020830 SINGULAIR | Organon | February 20, 1998 | 54, latest February 22, 2021 2021: Labeling · 2020: Labeling · 2019: Labeling |
| NDA021409 SINGULAIR | Organon | July 26, 2002 | 33, latest February 22, 2021 2021: Labeling · 2020: Labeling · 2019: Labeling |
Generic approvals (25)
- ANDA090984Torrent Pharms Ltd · August 3, 2012
- ANDA200405Lannett Co Inc · August 3, 2012
- ANDA200889Aiping Pharm Inc · August 3, 2012
- ANDA201515Torrent Pharms Ltd · August 3, 2012
- ANDA202096Aurobindo Pharma Ltd · August 3, 2012
- ANDA202468Aurobindo Pharma Ltd · August 3, 2012
- ANDA201581Pharmazone · August 6, 2012
- ANDA201582DR Reddys Labs Ltd · August 6, 2012
- ANDA202717Accord Hlthcare · September 21, 2012
- ANDA202843Hetero Labs Ltd V · September 10, 2014
- ANDA203366Macleods Pharms · September 11, 2014
- ANDA203037Pharmobedient · October 30, 2014
- ANDA203582Macleods Pharms · March 12, 2015
- ANDA204093Hetero Labs Ltd V · May 22, 2015
- ANDA203328Ajanta Pharma Ltd · July 31, 2015
- ANDA203432Ajanta Pharma Ltd · July 31, 2015
- ANDA203438Ajanta Pharma Ltd · July 31, 2015
- ANDA204604Amneal Pharms · September 4, 2015
- ANDA204290Unichem · October 8, 2015
- ANDA205683Anbison Lab · January 12, 2016
- ANDA209012Rising · April 24, 2017
- ANDA208621Unichem · July 2, 2018
- ANDA210431Torrent · July 31, 2018
- ANDA213471Aurobindo Pharma Ltd · February 18, 2020
- ANDA205107Amneal Pharms · September 4, 2020
Shortage status
To be discontinued · updated November 17, 2025 · first posted November 17, 2025
| Product | Singulair, Tablet, Chewable, 4 mg (NDC 78206-170-01) |
|---|---|
| Company | Organon |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
October 13, 2023 · Class II · Terminated · D-0086-2024
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10. — Dr. Reddy's Laboratories, Inc.
-
February 7, 2023 · Class II · Terminated · D-0400-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 — Accord Healthcare, Inc.
-
January 20, 2020 · Class III · Terminated · D-0823-2020
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111 — Macleods Pharma Usa Inc
-
August 20, 2018 · Class II · Terminated · D-1213-2018
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, N — Hetero Labs Limited Unit V
-
August 15, 2018 · Class I · Ongoing · D-0081-2019
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 088 — Hetero Labs Limited Unit V
-
January 7, 2017 · Class III · Terminated · D-0623-2017
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, N — Hetero USA Inc
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) — Singulair, Organon LLC, effective April 30, 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 →