Quick answers
- What is Tranexamic acid used for?
- The FDA-approved label (Cyklokapron, Pfizer Laboratories Div Pfizer Inc, September 3, 2025) says: “CYKLOKAPRON ® is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tranexamic acid have a boxed warning?
- Yes. The FDA label for Cyklokapron has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tranexamic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tranexamic acid been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started June 13, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Tranexamic acid?
- 37 companies list prescription products of Tranexamic acid in the FDA NDC Directory, including Bryant Ranch Prepack, Sagent Pharmaceuticals and Amneal Pharmaceuticals Private Limited.
What Tranexamic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CYKLOKAPRON ® is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. …
— FDA label: Cyklokapron, Pfizer Laboratories Div Pfizer Inc, effective September 3, 2025. Read the full label on DailyMed →
The FDA has 39 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
6 of 39 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Tablet · Injection · Tablet, film coated |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 51 in the FDA NDC Directory |
| Brand names | Cyklokapron |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tranexamic acid 1 g/10 mL injection, solution | Generic | $0.3970 per mL |
| tranexamic acid 100 mg/mL injection | Generic | $0.3970 per mL |
| tranexamic acid 100 mg/mL injection, solution | Generic | $0.3970 per mL |
| tranexamic acid 650 mg tablet | Generic | $0.8295 per tablet |
| tranexamic acid 650 mg tablet, film coated | Generic | $0.8295 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack4 products
- Sagent Pharmaceuticals3 products
- Amneal Pharmaceuticals Private Limited2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Gland Pharma Limited2 products
- NorthStar Rx LLC2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Avenacy Inc.2 products
- Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.2 products
- Micro Labs Limited2 products
- Milla Pharmaceuticals Inc.2 products
- Provepharm Inc.2 products
- Armas Pharmaceuticals Inc.2 products
- Nexus Pharmaceuticals LLC1 product
- Eugia US LLC1 product
- i3 Pharmaceuticals, LLC1 product
- Fresenius Kabi USA, LLC1 product
- Pfizer Laboratories Div Pfizer Inc1 product
- Caplin Steriles Limited1 product
- Remedyrepack Inc.1 product
- Exela Pharma Sciences, LLC1 product
- Emcure Pharmaceuticals Limited1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Aurobindo Pharma Limited1 product
- ANI Pharmaceuticals, Inc.1 product
- American Health Packaging1 product
- Hp Halden Pharma AS1 product
- Advagen Pharma Limited1 product
- Dr. Reddy's Laboratories Inc.1 product
- Baxter Healthcare Corporation1 product
- Nordic Pharma, Inc.1 product
- Actavis Pharma, Inc.1 product
- Proficient Rx LP1 product
- AvPAK1 product
- Apotex Corp.1 product
- Mylan Institutional LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019281 CYKLOKAPRON | Pfizer | December 30, 1986 | 33, latest August 29, 2025 2025: Labeling · 2021: Labeling · 2020: Labeling |
| NDA022430 LYSTEDA | J Molner | November 13, 2009 | 6, latest December 7, 2020 2020: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA212020 TRANEXAMIC ACID | Exela Pharma | April 15, 2019 | 1, latest July 16, 2020 2020: Labeling |
Generic approvals (22)
- ANDA091657Mylan Institutional · November 3, 2011
- ANDA202093Actavis Labs Fl Inc · December 27, 2012
- ANDA201580Pharmobedient · June 14, 2013
- ANDA202436Heritage · February 11, 2014
- ANDA203521Avet Lifesciences · August 12, 2014
- ANDA205133Aurobindo Pharma USA · September 21, 2015
- ANDA205035Eugia Pharma · January 14, 2016
- ANDA203256Ani Pharms · July 25, 2016
- ANDA207239Gland · February 13, 2017
- ANDA208840Amneal Pharms Co · February 28, 2017
- ANDA206713Micro Labs · June 27, 2017
- ANDA212360Caplin · July 17, 2019
- ANDA212676Milla Pharms · July 17, 2019
- ANDA209860Apotex · January 14, 2020
- ANDA217155Amneal · October 16, 2023
- ANDA216877Nexus · April 16, 2024
- ANDA218599Gland · April 16, 2024
- ANDA218320Rubicon Research · June 11, 2024
- ANDA218242Fresenius Kabi USA · August 15, 2024
- ANDA218896Heritage · June 2, 2025
- ANDA218729Appco · June 11, 2025
- ANDA219702Pharmazone · January 26, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 13, 2023 · Class III · Ongoing · D-0875-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 — AVKARE LLC
-
June 12, 2023 · Class III · Terminated · D-0871-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 — Amring Pharmaceuticals Inc
-
September 26, 2022 · Class III · Ongoing · D-1551-2022
Presence of Particulate Matter: Piece of metal found in a vial
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10 — AuroMedics Pharma LLC
-
August 17, 2020 · Class I · Terminated · D-1576-2020
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ire — Mylan Institutional LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 208104, 238720, 883826, 2170286 |
|---|---|
| SPL set ID of the quoted label | 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5 |
| FDA labels (SPL) | 39 |
| FDA applications | NDA019281, NDA022430, NDA212020, 22 ANDA |
| Active ingredients (FDA) | TRANEXAMIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cyklokapron, Pfizer Laboratories Div Pfizer Inc, effective September 3, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →