Medicine
Fexinidazole 600 mg tablet
Fexinidazole 600 mg tablet is a generic prescription medicine for oral use, 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 below 30°C (86°F). Store in the original package in order to protect…
Key facts
- Active ingredient (INN)
- Fexinidazole
- Brand
- Sold under the generic name
- Strength
- 600 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 14 tablets, 24 tablets
- Manufacturer
- Sanofi-Aventis
- Origin register
- US FDA, United States
- Storage
- Store below 30°C (86°F). Store in the original package in order to protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- P01CA03 Fexinidazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2021
- Identifiers
- RxCUI 2564151, 2564152, 2564153DailyMed set ID 74a611bc-9977-46bb-b626-0370b3031628NDC 0024-4512Application NDA214429
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 |
|---|---|---|---|
| 14 tablet in 1 dose pack | 0024-4512-14 | Sanofi-Aventis | 16 July 2021 |
| 24 tablet in 1 dose pack | 0024-4512-24 | Sanofi-Aventis | 16 July 2021 |
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 16 July 2021 | 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
Clinical summary
Fexinidazole is a nitroimidazole antimicrobial. It is available as tablets for oral use. MedsAcross supplies Fexinidazole 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 FexinidazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fexinidazole prescribing information (Sanofi-Aventis) · U.S. National Library of Medicine, DailyMed
Need Fexinidazole 600 mg tablet 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.