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United States · US · US:60505-3803_6c941626-eccb-8cc5-eea9-cf3bc4ee3f0e
Nilotinib
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116050538037120 CAPSULE in 1 BOTTLE (60505-3803-7)
Annotations
UNII (FDA Substance ID)
F41401512X
NILOTINIB
RxCUI 662281
Orange Book
A203640
ABABAB
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": "60505-3803_6c941626-eccb-8cc5-eea9-cf3bc4ee3f0e",
"productndc": "60505-3803",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203640",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Jan 5, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Jan 5, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "003",
"approval_date": "Jan 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NILOTINIB",
"proprietary_name": "Nilotinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203640",
"marketing_category": "ANDA",
"nonproprietary_name": "nilotinib",
"start_marketing_date": "20250523",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EA03.
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