Medicine
Tranexamic acid 1000 mg/100 mL injection
Tranexamic acid 1000 mg/100 mL injection is a generic prescription medicine for intravenous use, made by 8 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 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Tranexamic acid
- Brand
- Sold under the generic name
- Strength
- 1000 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 pouches of 100 mL, 12 pouches of 100 mL, 100 mL and 7 more
- Manufacturers
- Gland PharmaIndiaAmneal PharmaceuticalsAvenacyExela Pharma SciencesFresenius KabiHp Halden PharmaNexus PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 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
- 1 June 2019
- Identifiers
- RxCUI 2170286DailyMed set ID c479dccd-15c6-47c2-9675-680ebb9db2cb, 80465b90-3f92-4e35-b2ba-69871bbd4a7f, 0c638812-ba60-49fe-a715-f40246b6cbf7 +6NDC 14789-115, 25021-418, 66298-5340 +5Application ANDA216877, ANDA218599, ANDA218242 +3
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 |
|---|---|---|---|
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 68083-613-10 | Gland PharmaIndia | 16 April 2024 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 80830-2329-2 | Amneal Pharmaceuticals | 23 October 2023 |
| 12 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 80830-2329-3 | Amneal Pharmaceuticals | 8 January 2024 |
| 10 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 80830-2329-4 | Amneal Pharmaceuticals | 9 July 2025 |
| 100 mL in 1 bag | 51754-0108-1 | Exela Pharma Sciences | 1 June 2019 |
| 24 bag in 1 case / 100 mL in 1 bag | 65219-534-10 | Fresenius Kabi | 1 December 2024 |
| 24 bag in 1 case / 100 mL in 1 bag | 66298-5340-1 | HP Halden Pharma | 10 December 2024 |
| 10 bag in 1 carton / 100 mL in 1 bag | 14789-115-05 | Nexus Pharmaceuticals | 25 June 2024 |
| 10 bag in 1 carton / 100 mL in 1 bag | 25021-418-82 | Sagent Pharmaceuticals | 15 September 2024 |
| 10 vial, single-dose in 1 carton / 100 mL in 1 vial, single-dose | 83634-403-51 | Avenacy | 1 September 2025 |
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 1000 mg/100 mL injection 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.