Medicine
Tranexamic acid 650 mg tablet
Tranexamic acid 650 mg tablet is a generic prescription medicine for oral use, made by 14 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature 25°C (77° F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tranexamic acid
- Brand
- Sold under the generic name
- Strength
- 650 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 20 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackAdvagen PharmaActavis PharmaAmerican Health PackagingANI PharmaceuticalsAvPAK
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 25°C (77° F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02AA02 Tranexamic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 January 2013
- Identifiers
- RxCUI 883826DailyMed set ID 2c48c13a-5e7d-43ef-81a3-27d3bcda0f80, e5a52dad-e328-48f2-9182-4df46f5572ef, af95be04-a6ea-4789-8e79-7dcad332c640 +14NDC 72319-028, 75907-309, 71335-1981 +14Application ANDA219702, ANDA218729, ANDA203256 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 59651-839-30 | Aurobindo PharmaIndia | 4 December 2023 |
| 30 tablet in 1 bottle | 75907-309-30 | Dr. Reddy's LaboratoriesIndia | 1 August 2025 |
| 30 tablet in 1 bottle | 72578-220-06 | Viona PharmaceuticalsIndia | 1 November 2026 |
| 30 tablet in 1 bottle | 70771-1989-3 | Zydus LifesciencesIndia | 1 November 2026 |
| 30 tablet, film coated in 1 bottle, plastic | 0591-3720-30 | Actavis Pharma | 3 January 2013 |
| 100 tablet in 1 bottle | 72888-178-01 | Advagen Pharma | 11 June 2024 |
| 500 tablet in 1 bottle | 72888-178-05 | Advagen Pharma | 11 June 2024 |
| 30 tablet in 1 bottle | 72888-178-30 | Advagen Pharma | 11 June 2024 |
| 30 tablet in 1 bottle | 62559-265-30 | ANI Pharmaceuticals | 1 July 2021 |
| 30 tablet in 1 bottle, plastic | 72319-028-01 | i3 Pharmaceuticals | 30 June 2026 |
| 30 tablet in 1 bottle | 69918-301-30 | Nordic Pharma | 1 March 2016 |
| 8 tablet, film coated in 1 bottle, plastic | 63629-8599-1 | Bryant Ranch Prepack | 28 June 2021 |
| 30 tablet, film coated in 1 bottle, plastic | 63629-8838-1 | Bryant Ranch Prepack | 10 September 2021 |
| 8 tablet in 1 bottle | 71335-1981-1 | Bryant Ranch Prepack | 22 October 2021 |
| 30 tablet in 1 bottle | 71335-1981-2 | Bryant Ranch Prepack | 31 May 2024 |
| 4 tablet in 1 bottle | 71335-1981-3 | Bryant Ranch Prepack | 27 September 2022 |
| 8 tablet in 1 bottle | 71335-2695-1 | Bryant Ranch Prepack | 24 September 2025 |
| 30 tablet in 1 bottle | 71335-2695-2 | Bryant Ranch Prepack | 24 September 2025 |
| 4 tablet in 1 bottle | 71335-2695-3 | Bryant Ranch Prepack | 24 September 2025 |
| 30 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-750-21 | American Health Packaging | 1 October 2023 |
| 30 blister pack in 1 box / 1 tablet in 1 blister pack | 50268-772-13 | AvPAK | 16 September 2022 |
| 30 tablet in 1 bottle | 72603-818-01 | NorthStar Rx | 1 August 2026 |
| 15 tablet in 1 bottle | 82804-208-15 | Proficient Rx | 11 June 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 December 1986 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Tranexamic acid
Clinical summary
Tranexamic acid is an antifibrinolytic agent 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. MedsAcross supplies Tranexamic acid for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Tranexamic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cyklokapron prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Tranexamic acid 650 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.