Drug
Who makes isosorbide mononitrate?
23 companies list isosorbide mononitrate as a human prescription drug. Forms: tablet; tablet, extended release. 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 isosorbide mononitrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet, extended release | ANDAANDA210918, ANDA216557 | 5 | 3 |
| Coupler LLCUnited States | tablet; tablet, extended release | ANDA, NDA AUTHORIZED GENERICANDA075147, ANDA075522, ANDA216557 | 5 | 1 |
| Aurobindo Pharma LimitedIndia | tablet, extended release | ANDAANDA216557 | 3 | 6 |
| Torrent Pharma, Inc.India | tablet, extended release | ANDAANDA200270, ANDA200495 | 3 | 5 |
| Bryant Ranch PrepackUnited States | tablet, extended release | ANDAANDA075522, ANDA210918 | 3 | 1 |
| Golden State Medical Supply Inc.United States | tablet, extended release | ANDAANDA210918 | 3 | 1 |
| Shandong New Time Pharmaceutical Co., Ltd.China | tablet, extended release | ANDAANDA214115 | 3 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, extended release | ANDAANDA210918 | 3 | 0 |
| Chartwell RX, LLC. | tablet, extended release | ANDAANDA075522, ANDA210822 | 3 | 0 |
| Edenbridge Pharmaceuticals LLC. | tablet, extended release | ANDAANDA075522, ANDA210822 | 3 | 0 |
| Ingenus Pharmaceuticals, LLC | tablet, extended release | ANDAANDA210918 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet, extended release | ANDAANDA200270, ANDA200495 | 2 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, extended release | ANDAANDA200270, ANDA200495 | 2 | 5 |
| Genus Lifesciences Inc.United States | tablet | ANDAANDA075037 | 2 | 2 |
| ANI Pharmaceuticals, Inc.United States | tablet | ANDAANDA075147 | 2 | 1 |
| Lannett Company, LLCUnited States | tablet | NDA AUTHORIZED GENERICNDA020215 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, extended release | ANDAANDA200270, ANDA200495 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, extended release | ANDAANDA200270, ANDA200495 | 2 | 0 |
| Omnivium Pharmaceuticals LLC | tablet | NDA AUTHORIZED GENERICNDA020215 | 2 | 0 |
| Northwind Health Company, LLCUnited States | tablet, extended release | ANDAANDA210918 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, extended release | ANDAANDA075522 | 1 | 1 |
| Proficient Rx LPUnited States | tablet | NDA AUTHORIZED GENERICNDA020215 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet, extended release | ANDAANDA200270 | 1 | 1 |
Enquiry
Common questions
- Who makes isosorbide mononitrate?
- 23 companies list isosorbide mononitrate as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Coupler LLC, Aurobindo Pharma Limited, Torrent Pharma, Inc., Bryant Ranch Prepack. 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 isosorbide mononitrate?
- 20 companies list isosorbide mononitrate 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.