Medicine
Tranexamic acid 1000 mg/10 mL injection
Tranexamic acid 1000 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 20 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 20ºC to 25°C (68ºF 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/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 ampules of 10 mL, 10 vials of 10 mL, 10 cartons of 10 mL and 26 more
- Manufacturers
- Avet PharmaceuticalsIndiaAvet Pharmaceuticals LabsIndiaMicro LabsIndiaCaplin SterilesIndiaEmcure PharmaceuticalsIndiaEugiaIndiaGland PharmaIndiaArmas PharmaceuticalsHealthFirstProvepharm
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25°C (68ºF 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
- 29 November 2011
- Identifiers
- RxCUI 238720DailyMed set ID fb2fcae9-6aa0-4708-b250-b0e40beb147e, 00630e54-0e84-465d-96a5-63486c87dcd9, 0277db2d-7c81-4cd0-ac19-fa12b5721428 +21NDC 71357-018, 83634-401, 25021-415 +23Application ANDA212676, ANDA203521, ANDA207239 +8
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 ampule in 1 carton / 10 mL in 1 ampule | 23155-909-41 | Avet PharmaceuticalsIndia | 25 November 2024 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 23155-910-41 | Avet PharmaceuticalsIndia | 25 November 2024 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 23155-166-41 | Avet Pharmaceuticals LabsIndia | 13 August 2014 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 23155-524-41 | Avet Pharmaceuticals LabsIndia | 13 August 2014 |
| 10 carton in 1 carton / 1 ampule in 1 carton / 10 mL in 1 ampule | 42571-189-57 | Micro LabsIndia | 1 August 2017 |
| 10 carton in 1 carton / 1 vial, glass in 1 carton / 10 mL in 1 vial, glass | 42571-314-89 | Micro LabsIndia | 1 August 2017 |
| 10 vial in 1 box / 10 mL in 1 vial | 65145-106-10 | Caplin SterilesIndia | 3 January 2025 |
| 10 vial in 1 carton / 10 mL in 1 vial | 14593-318-01 | Emcure PharmaceuticalsIndia | 28 October 2024 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-188-10 | EugiaIndia | 14 January 2016 |
| 10 vial in 1 carton / 10 mL in 1 vial | 68083-160-10 | Gland PharmaIndia | 22 February 2017 |
| 1 vial, glass in 1 carton / 10 mL in 1 vial, glass | 72485-107-01 | Armas Pharmaceuticals | 11 June 2021 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 72485-107-10 | Armas Pharmaceuticals | 11 June 2021 |
| 10 vial in 1 carton / 10 mL in 1 vial | 72485-510-10 | Armas Pharmaceuticals | 6 February 2024 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 81284-611-10 | Provepharm | 30 September 2021 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 81284-612-10 | Provepharm | 30 September 2021 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-415-10 | Sagent Pharmaceuticals | 15 July 2023 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-415-66 | Sagent Pharmaceuticals | 15 October 2025 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 70121-1398-1 | Amneal Pharmaceuticals | 28 February 2017 |
| 10 vial in 1 carton / 10 mL in 1 vial | 60505-6169-1 | Apotex | 5 August 2020 |
| 10 carton in 1 box / 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 43066-008-10 | Baxter Healthcare | 1 July 2020 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71357-018-10 | Milla Pharmaceuticals | 31 August 2026 |
| 10 vial, single-dose in 1 package / 10 mL in 1 vial, single-dose | 67457-197-10 | Mylan Institutional | 29 November 2011 |
| 10 vial in 1 carton / 10 mL in 1 vial | 39822-1000-1 | XGen Pharmaceuticals DJB | 18 May 2012 |
| 10 mL in 1 vial, single-dose | 51662-1532-1 | HealthFirst | 20 June 2021 |
| 10 pouch in 1 case / 1 vial, single-dose in 1 pouch / 10 mL in 1 vial, single-dose | 51662-1532-3 | HealthFirst | 20 June 2021 |
| 10 mL in 1 vial | 51662-1714-1 | HealthFirst | 15 July 2023 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 83634-401-10 | Avenacy | 1 June 2024 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 72603-387-10 | Northstar Rx | 25 November 2024 |
| 10 carton in 1 box / 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 70518-4089-0 | Remedyrepack | 1 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
Alternatives
Other makers and brands of Tranexamic acid 1000 mg/10 mL injection.
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/10 mL injection for your hospital or patient?
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