Medicine
Recothrom kit
Recothrom kit is a prescription medicine containing Thrombin topical recombinant, marketed by Baxter Healthcare, 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
Do not freeze. Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to…
Key facts
- Active ingredient (INN)
- Thrombin topical recombinant
- Brand
- Recothrom
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Baxter Healthcare
- Manufacturer
- Baxter Healthcare
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 January 2008
- Identifiers
- RxCUI 1367418, 1367420DailyMed set ID 54885644-e51e-4263-aadb-366abaeb56a3NDC 0338-0330, 0338-0322, 0338-0326Application BLA125248
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 kit in 1 kit * 5 mL in 1 vial * 5 mL in 1 syringe | 0338-0322-01 | Baxter Healthcare | 29 January 2008 |
| 1 kit in 1 kit * 20 mL in 1 vial * 20 mL in 1 syringe | 0338-0326-01 | Baxter Healthcare | 9 June 2008 |
| 1 kit in 1 kit * 20 mL in 1 vial * 20 mL in 1 vial | 0338-0330-01 | Baxter Healthcare | 9 June 2008 |
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 |
| 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
Clinical summary
Thrombin topical recombinant is a prescription medicine. It is available as kits. MedsAcross supplies Thrombin topical recombinant 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 Thrombin topical recombinantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RECOTHROM prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
Need Recothrom kit 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.