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United States · US · US:50419-750_9b14492a-5ae2-4d0a-85c0-212636daf8cd
LAMPIT
Orange BookUNIISPLATC P01CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeP01CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150419750011 BOTTLE in 1 CARTON (50419-750-01) / 100 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
M84I3K7C2O
NIFURTIMOX
RxCUI 7421
Orange Book
N213464
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M84I3K7C2O",
"rxcui": "7421",
"inchikey": "ARFHIAQFJWUCFH-IZZDOVSWSA-N",
"display_name": "NIFURTIMOX",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"90d09714-a8b1-4696-8ada-f99dc54d0721": {
"match": "brand_token",
"title": "LAMPIT (NIFURTIMOX) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "9",
"published_date": "2026-03-05"
}
},
"productid": "50419-750_9b14492a-5ae2-4d0a-85c0-212636daf8cd",
"productndc": "50419-750",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213464",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "30MG",
"product_no": "001",
"approval_date": "Aug 6, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "120MG",
"product_no": "002",
"approval_date": "Aug 6, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFURTIMOX",
"proprietary_name": "LAMPIT",
"active_ingred_unit": "mg/1",
"application_number": "NDA213464",
"marketing_category": "NDA",
"nonproprietary_name": "nifurtimox",
"start_marketing_date": "20201001",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code P01CC01.
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