🇺🇸
United States · US · US:69051-300_463f0c82-b948-2b96-e063-6394a90aecf0
IMPAVIDO
Orange BookUNIISPLATC P01CX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProfounda, Inc.
CountryUS (United States)
ATC codeP01CX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169051300012 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
53EY29W7EC
MILTEFOSINE
RxCUI 1494066
Orange Book
N204684
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "53EY29W7EC",
"rxcui": "1494066",
"inchikey": "PQLXHQMOHUQAKB-UHFFFAOYSA-N",
"display_name": "MILTEFOSINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bcb387ac-2e90-4f5e-94b2-d3635190678e": {
"match": "brand_token",
"title": "IMPAVIDO (MILTEFOSINE) CAPSULE [PROFOUNDA, INC.]",
"spl_version": "13",
"published_date": "2026-02-11"
}
},
"productid": "69051-300_463f0c82-b948-2b96-e063-6394a90aecf0",
"productndc": "69051-300",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204684",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Mar 19, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MILTEFOSINE",
"proprietary_name": "IMPAVIDO",
"active_ingred_unit": "mg/1",
"application_number": "NDA204684",
"marketing_category": "NDA",
"nonproprietary_name": "miltefosine",
"start_marketing_date": "20151029",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code P01CX04.
Access this data programmatically
Query IMPAVIDO 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.