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United States · US · US:43598-055_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5
Nilotinib
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114359805504120 CAPSULE in 1 BOTTLE (43598-055-04)
Annotations
UNII (FDA Substance ID)
5JHU0N1R6K
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Orange Book
A218350
ABABAB
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": "43598-055_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5",
"productndc": "43598-055",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218350",
"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 HYDROCHLORIDE MONOHYDRATE",
"proprietary_name": "Nilotinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218350",
"marketing_category": "ANDA",
"nonproprietary_name": "Nilotinib",
"start_marketing_date": "20251119",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EA03.
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