Data / Drug companies / Isosorbide dinitrate
Isosorbide dinitrate: 18 companies and 55 products in the FDA NDC directory
Isosorbide dinitrate is listed in the FDA National Drug Code Directory by 18 companies, with 55 products in commercial distribution. 53 of the products (96.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, and the newest product started marketing on July 26, 2025.
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- Companies listing it
- 18
- Products
- 55
- Generic (ANDA) products
- 53 (96.4%)
- Application numbers
- 14
- Routes
- Oral
- Brand names
- Isosorbide
- openFDA record search
- api.fda.gov
Companies that list isosorbide dinitrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Advagen Pharma Ltd | 5 | tablet | Generic drugs (ANDA) | July 8, 2022 |
| Par Health USA, LLC | 5 | tablet | Generic drugs (ANDA) | December 21, 2021 |
| Zydus Lifesciences Limited | 5 | tablet | Generic drugs (ANDA) | November 25, 2019 |
| Zydus Pharmaceuticals USA Inc. | 5 | tablet | Generic drugs (ANDA) | November 25, 2019 |
| BluePoint Laboratories | 4 | tablet | Generic drugs (ANDA) | August 5, 2023 |
| NorthStar Rx LLC | 4 | tablet | Generic drugs (ANDA) | May 1, 2020 |
| AvPAK | 3 | tablet | Generic drugs (ANDA) | June 6, 2017 |
| Golden State Medical Supply, Inc. | 3 | tablet | Generic drugs (ANDA) | November 2, 1987 |
| Hikma Pharmaceuticals USA Inc. | 3 | tablet | Generic drugs (ANDA) | April 26, 1983 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 3 | tablet | Generic drugs (ANDA) | July 8, 2022 |
| Sandoz Inc | 3 | tablet | Generic drugs (ANDA) | January 7, 1988 |
| American Health Packaging | 2 | tablet | Generic drugs (ANDA) | October 21, 2013 |
| Cardinal Health 107, LLC | 2 | tablet | Generic drugs (ANDA) | April 26, 1983 |
| Major Pharmaceuticals | 2 | tablet | Generic drugs (ANDA) | April 26, 1983 |
| Oceanside Pharmaceuticals | 2 | tablet | New drug applications (NDA) | March 2, 2020 |
| Proficient Rx LP | 2 | tablet | Generic drugs (ANDA) | July 8, 2022 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | December 21, 2021 |
| Remedyrepack Inc. | 1 | tablet | Generic drugs (ANDA) | July 26, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 55 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 53 | 96.4% |
| New drug applications (NDA) | 2 | 3.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nitrate Vasodilator | 55 |
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.