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United States · US · US:0642-7463_3eddc863-2c5b-6505-e063-6394a90a2423
Benznidazole
Orange BookUNIISPLATC P01CA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExeltis USA, Inc.
CountryUS (United States)
ATC codeP01CA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1106427463121 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
YC42NRJ1ZD
BENZNIDAZOLE
RxCUI 18994
Orange Book
N209570
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YC42NRJ1ZD",
"rxcui": "18994",
"inchikey": "CULUWZNBISUWAS-UHFFFAOYSA-N",
"display_name": "BENZNIDAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8983d6a0-f63f-4f8e-bba4-38223f39e29b": {
"match": "brand_token",
"title": "BENZNIDAZOLE TABLET [EXELTIS USA, INC.]",
"spl_version": "13",
"published_date": "2025-09-22"
}
},
"productid": "0642-7463_3eddc863-2c5b-6505-e063-6394a90a2423",
"productndc": "0642-7463",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209570",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "12.5MG",
"product_no": "001",
"approval_date": "Aug 29, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Aug 29, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZNIDAZOLE",
"proprietary_name": "Benznidazole",
"active_ingred_unit": "mg/1",
"application_number": "NDA209570",
"marketing_category": "NDA",
"nonproprietary_name": "benznidazole",
"start_marketing_date": "20180330",
"active_numerator_strength": "12.5"
}Related drugs
Other records sharing ATC code P01CA02.
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