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United States · US · US:13668-710_8e83f910-85f0-4646-b330-179f02acddf7
nilotinib
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1113668710574 BLISTER PACK in 1 CARTON (13668-710-57) / 28 CAPSULE in 1 BLISTER PACK
- ndc1113668710911 BLISTER PACK in 1 CARTON (13668-710-91) / 28 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
5JHU0N1R6K
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Orange Book
A218532
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5JHU0N1R6K",
"rxcui": null,
"inchikey": "YCBPQSYLYYBPDW-UHFFFAOYSA-N",
"display_name": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
"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": "13668-710_8e83f910-85f0-4646-b330-179f02acddf7",
"productndc": "13668-710",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218532",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Dec 15, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "002",
"approval_date": "Dec 15, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
"proprietary_name": "nilotinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218532",
"marketing_category": "ANDA",
"nonproprietary_name": "nilotinib",
"start_marketing_date": "20251216",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01EA03.
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