Medicine
Sotradecol 20 mg/2 mL injection
Sotradecol 20 mg/2 mL injection is a prescription medicine containing Tetradecyl hydrogen sulfate (ester) for intravenous use, marketed by Mylan Institutional, 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Tetradecyl hydrogen sulfate (ester)
- Brand
- Sotradecol
- Strength
- 20 mg/2 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 5 vials of 2 mL
- Marketing authorisation holder
- Mylan Institutional
- Manufacturer
- Mylan Institutional
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 April 2013
- Identifiers
- RxCUI 204490, 204491, 543732 +1DailyMed set ID f1756c28-dcd2-4b49-be62-07ca20682018NDC 67457-162Application ANDA040541
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 |
|---|---|---|---|
| 5 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 67457-162-02 | Mylan Institutional | 29 April 2013 |
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
Alternatives
Other makers and brands of Tetradecyl hydrogen sulfate (ester) 20 mg/2 mL injection.
Other strengths and forms of Tetradecyl hydrogen sulfate (ester)
Clinical summary
Tetradecyl hydrogen sulfate (ester) is a prescription medicine indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. MedsAcross supplies Tetradecyl hydrogen sulfate (ester) 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 Tetradecyl hydrogen sulfate (ester)For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sotradecol prescribing information (Mylan Institutional) · U.S. National Library of Medicine, DailyMed
Need Sotradecol 20 mg/2 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.