Drug
Who makes montelukast sodium?
27 companies list montelukast sodium as a human prescription drug, including under the names SINGULAIR. Forms: granule; tablet; tablet, chewable; tablet, coated; 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 sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Proficient Rx LPUnited States | tablet; tablet, chewable; tablet, coated; tablet, film coated | ANDAANDA090984, ANDA200405, ANDA201515 | 9 | 1 |
| International Medication Systems, Ltd.United States | tablet, chewable; tablet, film coated | ANDAANDA202843, ANDA204093 | 5 | 3 |
| Torrent Pharma, Inc.India | granule; tablet; tablet, chewable | ANDAANDA090984, ANDA201515, ANDA210431 | 4 | 5 |
| Organon LLCNetherlands | granule; tablet, chewable; tablet, film coated | NDANDA020829, NDA020830, NDA021409 | 4 | 4 |
| Rising Pharma Holdings, Inc.United States | tablet; tablet, chewable; tablet, film coated | ANDAANDA202096, ANDA202468, ANDA209012 | 4 | 1 |
| Aurobindo Pharma LimitedIndia | granule; tablet, chewable; tablet, film coated | ANDAANDA202096, ANDA202468, ANDA213471 | 3 | 6 |
| Unichem Laboratories Limited, IndiaIndia | tablet, chewable; tablet, film coated | ANDAANDA204290, ANDA208621 | 3 | 5 |
| Ajanta Pharma LimitedIndia | granule; tablet, chewable; tablet, coated | ANDAANDA203328, ANDA203432, ANDA203438 | 3 | 2 |
| Bryant Ranch PrepackUnited States | tablet, chewable; tablet, film coated | ANDAANDA202717, ANDA204093, ANDA204290 | 3 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet, chewable; tablet, film coated | ANDAANDA202843, ANDA204093 | 3 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA202717, ANDA204290 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, chewable; tablet, film coated | ANDAANDA090984, ANDA202468, ANDA202717 | 3 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet; tablet, chewable; tablet, film coated | ANDAANDA201515, ANDA204093, ANDA204290 | 3 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | tablet, chewable | ANDAANDA201581 | 2 | 15 |
| Macleods Pharmaceuticals LimitedIndia | tablet, chewable | ANDAANDA203582 | 2 | 5 |
| Direct RxUnited States | tablet, chewable; tablet, film coated | ANDAANDA202843, ANDA204093 | 2 | 1 |
| Lannett Company, LLCUnited States | tablet, chewable | ANDAANDA200405 | 2 | 1 |
| AvKARE | tablet, chewable | ANDAANDA200405 | 2 | 0 |
| AvPAK | tablet, chewable | ANDAANDA200405 | 2 | 0 |
| Chartwell RX, LLC. | tablet, chewable | ANDAANDA200405 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA202843 | 1 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, coated | ANDAANDA201582 | 1 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA202717 | 1 | 2 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA202717 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA209012 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA202843 | 1 | 0 |
| Westminster Pharmaceuticals, LLC | tablet | ANDAANDA205683 | 1 | 0 |
Bulk ingredient listings
- Aurobindo Pharma LimitedIndia · 2 NDC
- Morepen Laboratories LimitedIndia · 2 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- LAURUS LABS LIMITEDIndia · 1 NDC
- MSD International GmbH · 1 NDC
- MSN Pharmachem Private LimitedIndia · 1 NDC
- Macleods Pharmaceuticals LimitedIndia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Teva API India Private Ltd.India · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Zenfold Sustainable Technologies Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes montelukast sodium?
- 27 companies list montelukast sodium as a human prescription drug in the openFDA NDC Directory, led by Proficient Rx LP, International Medication Systems, Ltd., Torrent Pharma, Inc., Organon LLC, Rising Pharma Holdings, Inc.. 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 SINGULAIR?
- 26 companies list montelukast sodium under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies montelukast sodium active ingredient?
- 12 companies list montelukast sodium as a bulk ingredient, including Aurobindo Pharma Limited, Morepen Laboratories Limited, Dr. Reddy's Laboratories Limited, LAURUS LABS LIMITED.