United States· US:0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832

Fexinidazole

A fexinidazole product containing fexinidazole, registered in United States by Sanofi-Aventis U.S. LLC. The same ATC class is registered in 2 of our 19 countries.

ATC P01CA03US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedFexinidazoleATCP01CA03REGISTER NO.US:0024-4512_1b3dbe65…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Fexinidazole is registered in 2 of 19 countries.

Countries holding a registration under ATC P01CA03 (fexinidazole), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 1 of them publish a price we can compare per daily dose

Fexinidazole · ATC P01CA03

2 / 19 countries

  • Denmark
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FEXINIDAZOLE
Manufacturer
Sanofi-Aventis U.S. LLC
Country
United States (US)
ATC code
P01CA03
ATC class
Fexinidazole
Defined daily dose
1.44 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0024-4512-14
  • ndc11
    0024-4512-24

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same class

Other records under P01CA03

Fexinidazole, as other registers publish it.

All fexinidazole products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/b178c18e-a4b3-4883-a7cc-d0d40d61564b
GET /v1/drugs/b178c18e-a4b3-4883-a7cc-d0d40d61564b?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "600",
  "substance": "FEXINIDAZOLE",
  "productndc": "0024-4512",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA214429",
  "marketing_category": "NDA"
}

See everything about fexinidazole.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.