Data / Drug companies / Isosorbide mononitrate
Isosorbide mononitrate: 25 companies and 62 products in the FDA NDC directory
Isosorbide mononitrate is listed in the FDA National Drug Code Directory by 25 companies, with 62 products in commercial distribution. 55 of the products (88.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, extended release; tablet, and the newest product started marketing on October 30, 2026.
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- Companies listing it
- 25
- Products
- 62
- Generic (ANDA) products
- 55 (88.7%)
- Application numbers
- 10
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list isosorbide mononitrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 5 | tablet, extended release | Generic drugs (ANDA) | November 7, 2022 |
| Coupler LLC | 5 | tablet; tablet, extended release | Generic drugs (ANDA) | July 6, 2026 |
| AiPing Pharmaceutical, Inc. | 3 | tablet, extended release | Generic drugs (ANDA) | October 30, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | 3 | tablet, extended release | Generic drugs (ANDA) | November 13, 2018 |
| Aurobindo Pharma Limited | 3 | tablet, extended release | Generic drugs (ANDA) | November 7, 2022 |
| Bryant Ranch Prepack | 3 | tablet, extended release | Generic drugs (ANDA) | November 13, 2018 |
| Chartwell RX, LLC | 3 | tablet, extended release | Generic drugs (ANDA) | November 15, 2018 |
| Edenbridge Pharmaceuticals LLC. | 3 | tablet, extended release | Generic drugs (ANDA) | November 15, 2018 |
| Golden State Medical Supply, Inc. | 3 | tablet, extended release | Generic drugs (ANDA) | November 5, 2018 |
| Ingenus Pharmaceuticals, LLC | 3 | tablet, extended release | Generic drugs (ANDA) | November 13, 2018 |
| Shandong New Time Pharmaceutical Co., Ltd. | 3 | tablet, extended release | Generic drugs (ANDA) | February 8, 2024 |
| Torrent Pharmaceuticals Limited | 3 | tablet, extended release | Generic drugs (ANDA) | June 3, 2011 |
| Actavis Pharma, Inc. | 2 | tablet | Generic drugs (ANDA) | October 30, 1998 |
| American Health Packaging | 2 | tablet, extended release | Generic drugs (ANDA) | June 10, 2024 |
| Ani Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | March 27, 2026 |
| Cardinal Health 107, LLC | 2 | tablet, extended release | Generic drugs (ANDA) | January 5, 2015 |
| Genus Lifesciences | 2 | tablet | Generic drugs (ANDA) | April 9, 2026 |
| Lannett Company, Inc. | 2 | tablet | Authorized generics (NDA) | June 30, 1993 |
| Major Pharmaceuticals | 2 | tablet, extended release | Generic drugs (ANDA) | January 5, 2015 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 2 | tablet, extended release | Generic drugs (ANDA) | June 3, 2011 |
| Omnivium Pharmaceuticals LLC. | 2 | tablet | Authorized generics (NDA) | May 2, 2024 |
| Northwind Health Company, LLC | 1 | tablet, extended release | Generic drugs (ANDA) | March 18, 2022 |
| NuCare Pharmaceuticals,Inc. | 1 | tablet, extended release | Generic drugs (ANDA) | January 5, 2017 |
| Proficient Rx LP | 1 | tablet | Authorized generics (NDA) | June 30, 1993 |
| Remedyrepack Inc. | 1 | tablet, extended release | Generic drugs (ANDA) | December 3, 2020 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, extended release | 48 | 77.4% |
| Tablet | 14 | 22.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 55 | 88.7% |
| Authorized generics (NDA) | 7 | 11.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nitrate Vasodilator | 62 |
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.