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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.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.4injection, solution; injectionGeneric drugs (ANDA)November 25, 2024
Sagent Pharmaceuticals3injection, solutionGeneric drugs (ANDA)October 15, 2025
Amneal Pharmaceuticals Private Limited2injection, solutionGeneric drugs (ANDA)July 9, 2025
Armas Pharmaceuticals Inc.2injectionGeneric drugs (ANDA)February 6, 2024
Avenacy, LLC2injection, solutionGeneric drugs (ANDA)September 1, 2025
Bryant Ranch Prepack2tablet, film coatedGeneric drugs (ANDA)January 3, 2013
Bryant Ranch Prepack2tabletGeneric drugs (ANDA)June 11, 2024
Gland Pharma Limited2injection, solutionGeneric drugs (ANDA)April 16, 2024
HF Acquisition Co LLC, DBA HealthFirst2injection, solutionGeneric drugs (ANDA)July 15, 2023
Micro Labs Limited2injectionGeneric drugs (ANDA)August 1, 2017
Milla Pharmaceuticals Inc.2injection, solutionGeneric drugs (ANDA)September 30, 2021
NorthStar RxLLC2tablet; injectionGeneric drugs (ANDA)August 1, 2026
Provepharm Inc.2injection, solutionGeneric drugs (ANDA)September 30, 2021
Actavis Pharma, Inc.1tablet, film coatedGeneric drugs (ANDA)January 3, 2013
Advagen Pharma Ltd1tabletGeneric drugs (ANDA)June 11, 2024
American Health Packaging1tabletGeneric drugs (ANDA)October 1, 2023
Amneal Pharmaceuticals LLC1injection, solutionGeneric drugs (ANDA)February 28, 2017
Ani Pharmaceuticals, Inc.1tabletGeneric drugs (ANDA)July 1, 2021
Apotex Corp.1injection, solutionGeneric drugs (ANDA)August 5, 2020
Aurobindo Pharma Limited1tabletGeneric drugs (ANDA)December 4, 2023
AvPAK1tabletAuthorized generics (NDA)September 16, 2022
Baxter Healthcare Corporation1injectionGeneric drugs (ANDA)July 1, 2020
Caplin Steriles Limited1injectionGeneric drugs (ANDA)January 3, 2025
Dr. Reddy's Laboratories Inc.1tabletGeneric drugs (ANDA)August 1, 2025
Emcure Pharmaceuticals Limited1injection, solutionGeneric drugs (ANDA)October 28, 2024
Eugia US LLC1injection, solutionGeneric drugs (ANDA)January 14, 2016
Exela Pharma Sciences, LLC1injection, solutionNew drug applications (NDA)June 1, 2019
Fresenius Kabi USA, LLC1injection, solutionGeneric drugs (ANDA)December 1, 2024
Hp Halden Pharma As1injection, solutionGeneric drugs (ANDA)December 10, 2024
I3 Pharmaceuticals, LLC1tabletGeneric drugs (ANDA)June 30, 2026
Mylan Institutional LLC1injection, solutionGeneric drugs (ANDA)November 29, 2011
Nexus Pharmaceuticals LLC1injection, solutionGeneric drugs (ANDA)June 25, 2024
Nordic Pharma, Inc.1tabletAuthorized generics (NDA)March 1, 2016
Pfizer Laboratories Div Pfizer Inc1injection, solutionNew drug applications (NDA)December 30, 1986
Proficient Rx LP1tabletGeneric drugs (ANDA)June 11, 2024
Remedyrepack Inc.1injectionGeneric drugs (ANDA)June 1, 2024
Viona Pharmaceuticals Inc1tabletGeneric drugs (ANDA)November 1, 2026
XGen Pharmaceuticals DJB, Inc.1injection, solutionGeneric drugs (ANDA)May 18, 2012
Zydus Lifesciences Limited1tabletGeneric drugs (ANDA)November 1, 2026

Dosage forms

Dosage formProductsShare
Injection, solution2850.9%
Tablet1425.5%
Injection1018.2%
Tablet, film coated35.5%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)5192.7%
New drug applications (NDA)23.6%
Authorized generics (NDA)23.6%

Pharmacologic classes

ClassProducts
Antifibrinolytic Agent55

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.