Data / Drug companies / Argatroban
Argatroban: 12 companies and 18 products in the FDA NDC directory
Argatroban is listed in the FDA National Drug Code Directory by 12 companies, with 18 products in commercial distribution. 11 of the products (61.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, solution; solution, and the newest product started marketing on April 17, 2026.
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- Companies listing it
- 12
- Products
- 18
- Generic (ANDA) products
- 11 (61.1%)
- Application numbers
- 10
- Routes
- Intravenous
- openFDA record search
- api.fda.gov
Companies that list argatroban
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 4 | injection | New drug applications (NDA) | March 25, 2020 |
| Gland Pharma Limited | 2 | injection, solution; solution | Generic drugs (ANDA) | July 31, 2023 |
| Mullan Pharmaceutical Inc. | 2 | injection | Generic drugs (ANDA) | March 10, 2026 |
| Par Health USA, LLC | 2 | injection | Generic drugs (ANDA) | June 1, 2015 |
| Accord Healthcare Inc. | 1 | injection | New drug applications (NDA) | October 7, 2021 |
| Amneal Pharmaceuticals LLC | 1 | injection, solution | Generic drugs (ANDA) | January 26, 2018 |
| Caplin Steriles Limited | 1 | injection | Generic drugs (ANDA) | April 17, 2026 |
| Eugia US LLC | 1 | injection, solution | New drug applications (NDA) | November 27, 2018 |
| Fresenius Kabi USA, LLC | 1 | injection | Generic drugs (ANDA) | May 24, 2021 |
| Mylan Institutional LLC | 1 | injection, solution | Generic drugs (ANDA) | November 14, 2017 |
| Plano Pharmaceuticals Inc. | 1 | solution | New drug applications (NDA) | May 9, 2011 |
| Sagent Pharmaceuticals | 1 | injection, solution | Generic drugs (ANDA) | April 15, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 11 | 61.1% |
| Injection, solution | 5 | 27.8% |
| Solution | 2 | 11.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 11 | 61.1% |
| New drug applications (NDA) | 7 | 38.9% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anti-coagulant | 18 |
| Direct Thrombin Inhibitor | 18 |
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.