Data / Drug companies / Hydralazine hydrochloride and isosorbide dinitrate
Hydralazine hydrochloride and isosorbide dinitrate: 3 companies and 3 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Hydralazine hydrochloride and isosorbide dinitrate is listed in the FDA National Drug Code Directory by 3 companies, with 3 products in commercial distribution. 0 of the products (0.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, and the newest product started marketing on April 15, 2022.
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- Companies listing it
- 3
- Products
- 3
- Generic (ANDA) products
- 0 (0.0%)
- Application numbers
- 1
- Routes
- Oral
- Brand names
- Isosorbide Dinitrate and Hydralazine Hydrochloride, BiDil
- openFDA record search
- api.fda.gov
Companies that list hydralazine hydrochloride and isosorbide dinitrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Azurity Pharmaceuticals, Inc. | 1 | tablet, film coated | New drug applications (NDA) | December 5, 2012 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Authorized generics (NDA) | April 15, 2022 |
| Wilshire Pharmaceuticals, Inc. | 1 | tablet, film coated | Authorized generics (NDA) | April 15, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 3 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Authorized generics (NDA) | 2 | 66.7% |
| New drug applications (NDA) | 1 | 33.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Arteriolar Vasodilator | 3 |
| Nitrate Vasodilator | 3 |
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.