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United States · US · US:0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102
Tasigna
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11007805265128 CAPSULE in 1 BLISTER PACK (0078-0526-51)
- ndc1100780526874 BLISTER PACK in 1 CARTON (0078-0526-87) / 28 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
5JHU0N1R6K
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Orange Book
N022068
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": {
"6093952a-5248-45cb-ad17-33716a411146": {
"match": "brand_token",
"title": "TASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "42",
"published_date": "2025-12-18"
}
},
"productid": "0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102",
"productndc": "0078-0526",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "022068",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Oct 29, 2007"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Jun 17, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "003",
"approval_date": "Mar 22, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
"proprietary_name": "Tasigna",
"active_ingred_unit": "mg/1",
"application_number": "NDA022068",
"marketing_category": "NDA",
"nonproprietary_name": "nilotinib",
"start_marketing_date": "20071029",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01EA03.
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