Drug
Who makes montelukast?
16 companies list montelukast as a human prescription drug. Forms: tablet; tablet, chewable; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing montelukast
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Amneal Ireland LimitedIreland | tablet; tablet, chewable | ANDAANDA204604, ANDA205107 | 3 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA203366 | 2 | 1 |
| Proficient Rx LPUnited States | tablet, chewable | ANDAANDA203037, ANDA203328 | 2 | 1 |
| Macleods Pharmaceuticals LimitedIndia | tablet | ANDAANDA203366 | 1 | 5 |
| Sandoz Industrial Products S.AAustria | tablet, film coated | ANDAANDA200889 | 1 | 5 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA202843 | 1 | 3 |
| Ajanta Pharma LimitedIndia | tablet, chewable | ANDAANDA203328 | 1 | 2 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA202843 | 1 | 1 |
| Coupler LLCUnited States | tablet | ANDAANDA203366 | 1 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA202843 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA202843 | 1 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA202843 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA202843 | 1 | 0 |
| AvPAK | tablet, film coated | ANDAANDA202843 | 1 | 0 |
| BluePoint Laboratories Inc. | tablet | ANDAANDA203366 | 1 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet, film coated | ANDAANDA202843 | 1 | 0 |
Bulk ingredient listings
- Hetero Drugs LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes montelukast?
- 16 companies list montelukast as a human prescription drug in the openFDA NDC Directory, led by Amneal Ireland Limited, NuCare Pharmaceuticals,Inc., Proficient Rx LP, Macleods Pharmaceuticals Limited, Sandoz Industrial Products S.A. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic montelukast?
- 16 companies list montelukast under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies montelukast active ingredient?
- 1 company lists montelukast as a bulk ingredient, including Hetero Drugs Limited.