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United States · US · US:69097-030_d748f03e-56ba-48e2-ae13-e8e74fac55e7
Nilotinib
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116909703008120 CAPSULE in 1 BOTTLE, PLASTIC (69097-030-08)
- ndc1169097030637 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16)
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": "69097-030_d748f03e-56ba-48e2-ae13-e8e74fac55e7",
"productndc": "69097-030",
"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": "20250618",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EA03.
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