Data / Drug companies / Tranexamic acid
Tranexamic acid: 39 companies and 55 products in the FDA NDC directory
Tranexamic acid is listed in the FDA National Drug Code Directory by 39 companies, with 55 products in commercial distribution. 51 of the products (92.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; tablet; injection, and the newest product started marketing on November 1, 2026.
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- Companies listing it
- 39
- Products
- 55
- Generic (ANDA) products
- 51 (92.7%)
- Application numbers
- 26
- Routes
- Intravenous, Oral
- Brand names
- Cyklokapron
- openFDA record search
- api.fda.gov
Companies that list tranexamic acid
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 4 | injection, solution; injection | Generic drugs (ANDA) | November 25, 2024 |
| Sagent Pharmaceuticals | 3 | injection, solution | Generic drugs (ANDA) | October 15, 2025 |
| Amneal Pharmaceuticals Private Limited | 2 | injection, solution | Generic drugs (ANDA) | July 9, 2025 |
| Armas Pharmaceuticals Inc. | 2 | injection | Generic drugs (ANDA) | February 6, 2024 |
| Avenacy, LLC | 2 | injection, solution | Generic drugs (ANDA) | September 1, 2025 |
| Bryant Ranch Prepack | 2 | tablet, film coated | Generic drugs (ANDA) | January 3, 2013 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | June 11, 2024 |
| Gland Pharma Limited | 2 | injection, solution | Generic drugs (ANDA) | April 16, 2024 |
| HF Acquisition Co LLC, DBA HealthFirst | 2 | injection, solution | Generic drugs (ANDA) | July 15, 2023 |
| Micro Labs Limited | 2 | injection | Generic drugs (ANDA) | August 1, 2017 |
| Milla Pharmaceuticals Inc. | 2 | injection, solution | Generic drugs (ANDA) | September 30, 2021 |
| NorthStar RxLLC | 2 | tablet; injection | Generic drugs (ANDA) | August 1, 2026 |
| Provepharm Inc. | 2 | injection, solution | Generic drugs (ANDA) | September 30, 2021 |
| Actavis Pharma, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | January 3, 2013 |
| Advagen Pharma Ltd | 1 | tablet | Generic drugs (ANDA) | June 11, 2024 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | October 1, 2023 |
| Amneal Pharmaceuticals LLC | 1 | injection, solution | Generic drugs (ANDA) | February 28, 2017 |
| Ani Pharmaceuticals, Inc. | 1 | tablet | Generic drugs (ANDA) | July 1, 2021 |
| Apotex Corp. | 1 | injection, solution | Generic drugs (ANDA) | August 5, 2020 |
| Aurobindo Pharma Limited | 1 | tablet | Generic drugs (ANDA) | December 4, 2023 |
| AvPAK | 1 | tablet | Authorized generics (NDA) | September 16, 2022 |
| Baxter Healthcare Corporation | 1 | injection | Generic drugs (ANDA) | July 1, 2020 |
| Caplin Steriles Limited | 1 | injection | Generic drugs (ANDA) | January 3, 2025 |
| Dr. Reddy's Laboratories Inc. | 1 | tablet | Generic drugs (ANDA) | August 1, 2025 |
| Emcure Pharmaceuticals Limited | 1 | injection, solution | Generic drugs (ANDA) | October 28, 2024 |
| Eugia US LLC | 1 | injection, solution | Generic drugs (ANDA) | January 14, 2016 |
| Exela Pharma Sciences, LLC | 1 | injection, solution | New drug applications (NDA) | June 1, 2019 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | December 1, 2024 |
| Hp Halden Pharma As | 1 | injection, solution | Generic drugs (ANDA) | December 10, 2024 |
| I3 Pharmaceuticals, LLC | 1 | tablet | Generic drugs (ANDA) | June 30, 2026 |
| Mylan Institutional LLC | 1 | injection, solution | Generic drugs (ANDA) | November 29, 2011 |
| Nexus Pharmaceuticals LLC | 1 | injection, solution | Generic drugs (ANDA) | June 25, 2024 |
| Nordic Pharma, Inc. | 1 | tablet | Authorized generics (NDA) | March 1, 2016 |
| Pfizer Laboratories Div Pfizer Inc | 1 | injection, solution | New drug applications (NDA) | December 30, 1986 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | June 11, 2024 |
| Remedyrepack Inc. | 1 | injection | Generic drugs (ANDA) | June 1, 2024 |
| Viona Pharmaceuticals Inc | 1 | tablet | Generic drugs (ANDA) | November 1, 2026 |
| XGen Pharmaceuticals DJB, Inc. | 1 | injection, solution | Generic drugs (ANDA) | May 18, 2012 |
| Zydus Lifesciences Limited | 1 | tablet | Generic drugs (ANDA) | November 1, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 28 | 50.9% |
| Tablet | 14 | 25.5% |
| Injection | 10 | 18.2% |
| Tablet, film coated | 3 | 5.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 51 | 92.7% |
| New drug applications (NDA) | 2 | 3.6% |
| Authorized generics (NDA) | 2 | 3.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antifibrinolytic Agent | 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.