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United States · US · US:24338-155_62029a35-74af-47bc-9b7b-93dcaddfd278
DANZITEN
Orange BookUNIISPLATC L01EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124338155014 CARTON in 1 CARTON (24338-155-01) / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03)
Annotations
UNII (FDA Substance ID)
F41401512X
NILOTINIB
RxCUI 662281
Orange Book
N219293
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": {
"d288d165-3505-49bb-9b2e-124490d65f49": {
"match": "brand_token",
"title": "DANZITEN (NILOTINIB) TABLET [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-07-31"
}
},
"productid": "24338-155_62029a35-74af-47bc-9b7b-93dcaddfd278",
"productndc": "24338-155",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219293",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 71MG BASE",
"product_no": "001",
"approval_date": "Nov 7, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 95MG BASE",
"product_no": "002",
"approval_date": "Nov 7, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NILOTINIB",
"proprietary_name": "DANZITEN",
"active_ingred_unit": "mg/1",
"application_number": "NDA219293",
"marketing_category": "NDA",
"nonproprietary_name": "nilotinib",
"start_marketing_date": "20241130",
"active_numerator_strength": "95"
}Related drugs
Other records sharing ATC code L01EA03.
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