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United States · US · US:76282-788_dbdd9603-ecc5-472c-8ce9-7cec9aae11f9
Nilotinib
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEXELAN PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117628278812120 CAPSULE in 1 BOTTLE, PLASTIC (76282-788-12)
Annotations
UNII (FDA Substance ID)
F41401512X
NILOTINIB
RxCUI 662281
Orange Book
N218922
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F41401512X",
"rxcui": "662281",
"inchikey": "HHZIURLSWUIHRB-UHFFFAOYSA-N",
"display_name": "NILOTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4c0bc799-ce6a-822a-e063-6394a90ab748": {
"match": "brand_token",
"title": "NILOTINIB CAPSULE [AVKARE]",
"spl_version": "1",
"published_date": "2026-03-03"
}
},
"productid": "76282-788_dbdd9603-ecc5-472c-8ce9-7cec9aae11f9",
"productndc": "76282-788",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218922",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Feb 19, 2025"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Feb 19, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "003",
"approval_date": "Feb 19, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NILOTINIB",
"proprietary_name": "Nilotinib",
"active_ingred_unit": "mg/1",
"application_number": "NDA218922",
"marketing_category": "NDA",
"nonproprietary_name": "Nilotinib",
"start_marketing_date": "20251114",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EA03.
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