Medicine
Cyklokapron 1000 mg/10 mL injection
Cyklokapron 1000 mg/10 mL injection is a prescription medicine containing Tranexamic acid for intravenous use, marketed by Pfizer Laboratories, 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
- Cyklokapron
- Strength
- 1000 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 ampule of 10 mL, 10 vials of 10 mL
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturer
- Pfizer Laboratories
- 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
- 30 December 1986
- Identifiers
- RxCUI 208104, 238720DailyMed set ID 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5NDC 0013-1114Application NDA019281
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 ampule in 1 carton / 10 mL in 1 ampule | 0013-1114-15 | Pfizer Laboratories | 21 November 2018 |
| 10 vial in 1 box / 10 mL in 1 vial | 0013-1114-21 | Pfizer Laboratories | 30 December 1986 |
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 Cyklokapron 1000 mg/10 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.