Data / Drug companies / Montelukast
Montelukast: 17 companies and 20 products in the FDA NDC directory
Montelukast is listed in the FDA National Drug Code Directory by 17 companies, with 20 products in commercial distribution. 20 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; tablet, chewable, and the newest product started marketing on August 4, 2026.
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- Companies listing it
- 17
- Products
- 20
- Generic (ANDA) products
- 20 (100.0%)
- Application numbers
- 7
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list montelukast
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 3 | tablet, chewable; tablet | Generic drugs (ANDA) | September 4, 2020 |
| NuCare Pharmaceuticals,Inc. | 2 | tablet | Generic drugs (ANDA) | September 11, 2014 |
| A-S Medication Solutions | 1 | tablet, film coated | Generic drugs (ANDA) | September 10, 2014 |
| Ajanta Pharma USA Inc. | 1 | tablet, chewable | Generic drugs (ANDA) | August 13, 2015 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | February 11, 2021 |
| AvPAK | 1 | tablet, film coated | Generic drugs (ANDA) | February 8, 2022 |
| BluePoint Laboratories | 1 | tablet | Generic drugs (ANDA) | June 29, 2018 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | September 10, 2014 |
| Coupler LLC | 1 | tablet | Generic drugs (ANDA) | August 4, 2026 |
| Macleods Pharmaceuticals Limited | 1 | tablet | Generic drugs (ANDA) | September 11, 2014 |
| Preferred Pharmaceuticals Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | October 6, 2021 |
| Proficient Rx LP | 1 | tablet, chewable | Generic drugs (ANDA) | December 1, 2014 |
| Proficient Rx LP | 1 | tablet, chewable | Generic drugs (ANDA) | August 13, 2015 |
| Quallent Pharmaceuticals Health LLC | 1 | tablet, film coated | Generic drugs (ANDA) | June 7, 2022 |
| Remedyrepack Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | June 18, 2021 |
| Sandoz Inc | 1 | tablet, film coated | Generic drugs (ANDA) | August 3, 2012 |
| XLCare Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | February 11, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 9 | 45% |
| Tablet | 6 | 30% |
| Tablet, chewable | 5 | 25% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 20 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Leukotriene Receptor Antagonist | 20 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.