🇺🇸
United States · US · US:0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832
Fexinidazole
Orange BookUNIISPLATC P01CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeP01CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
306ERL82IR
FEXINIDAZOLE
RxCUI 2564146
Orange Book
N214429
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "306ERL82IR",
"rxcui": "2564146",
"inchikey": "MIWWSGDADVMLTG-UHFFFAOYSA-N",
"display_name": "FEXINIDAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"74a611bc-9977-46bb-b626-0370b3031628": {
"match": "brand_token",
"title": "FEXINIDAZOLE TABLET [SANOFI-AVENTIS U.S. LLC]",
"spl_version": "10",
"published_date": "2025-05-07"
}
},
"productid": "0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832",
"productndc": "0024-4512",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214429",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Jul 16, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FEXINIDAZOLE",
"proprietary_name": "Fexinidazole",
"active_ingred_unit": "mg/1",
"application_number": "NDA214429",
"marketing_category": "NDA",
"nonproprietary_name": "Fexinidazole",
"start_marketing_date": "20210716",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code P01CA03.
Access this data programmatically
Query Fexinidazole and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.