Data / Drug companies / Bivalirudin
Bivalirudin: 13 companies and 15 products in the FDA NDC directory
Bivalirudin is listed in the FDA National Drug Code Directory by 13 companies, with 15 products in commercial distribution. 11 of the products (73.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; injection, solution; injection, and the newest product started marketing on May 27, 2024.
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- Companies listing it
- 13
- Products
- 15
- Generic (ANDA) products
- 11 (73.3%)
- Application numbers
- 10
- Routes
- Intravenous, Intracavernous
- openFDA record search
- api.fda.gov
Companies that list bivalirudin
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 30, 2017 |
| Meitheal Pharmaceuticals Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 16, 2018 |
| Accord Healthcare Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 7, 2018 |
| Avenacy, LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 18, 2023 |
| Civica, Inc. | 1 | injection, powder, lyophilized, for solution | Authorized generics (NDA) | December 21, 2020 |
| Dr. Reddy's Laboratories Limited | 1 | injection | Generic drugs (ANDA) | May 31, 2017 |
| Eugia US LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 27, 2018 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 23, 2019 |
| Maia Pharmaceuticals, Inc. | 1 | injection, solution | New drug applications (NDA) | May 27, 2024 |
| Mylan Institutional LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | June 5, 2018 |
| Par Health USA, LLC | 1 | injection, solution | New drug applications (NDA) | June 19, 2023 |
| Sandoz Inc | 1 | injection, powder, lyophilized, for solution | Authorized generics (NDA) | June 15, 2015 |
| Slate Run Pharmaceuticals, LLC | 1 | injection, powder, lyophilized, for suspension | Generic drugs (ANDA) | June 30, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 11 | 73.3% |
| Injection, solution | 2 | 13.3% |
| Injection | 1 | 6.7% |
| Injection, powder, lyophilized, for suspension | 1 | 6.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 11 | 73.3% |
| Authorized generics (NDA) | 2 | 13.3% |
| New drug applications (NDA) | 2 | 13.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anti-coagulant | 15 |
| Direct Thrombin Inhibitor | 15 |
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.