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United States · US · US:72205-238_13b46e09-62d2-4ce9-b3c0-deafcb1f1842
nilotinib
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11722052386328 CAPSULE in 1 BLISTER PACK (72205-238-63)
- ndc1172205238644 BLISTER PACK in 1 CARTON (72205-238-64) / 28 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
F41401512X
NILOTINIB
RxCUI 662281
Orange Book
A218544
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": "72205-238_13b46e09-62d2-4ce9-b3c0-deafcb1f1842",
"productndc": "72205-238",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218544",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Nov 19, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Nov 19, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "003",
"approval_date": "Nov 19, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NILOTINIB",
"proprietary_name": "nilotinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218544",
"marketing_category": "ANDA",
"nonproprietary_name": "nilotinib",
"start_marketing_date": "20251119",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EA03.
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