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United States · US · US:0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756
ZYKADIA
Orange BookUNIISPLATC L01ED02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01ED02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11007806944821 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48)
- ndc11007806948484 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84)
Annotations
UNII (FDA Substance ID)
K418KG2GET
CERITINIB
RxCUI 1535457
Orange Book
N211225
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K418KG2GET",
"rxcui": "1535457",
"inchikey": "VERWOWGGCGHDQE-UHFFFAOYSA-N",
"display_name": "CERITINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fff5d805-4ffd-4e8e-8e63-6f129697563e": {
"match": "brand_token",
"title": "ZYKADIA (CERITINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "21",
"published_date": "2025-12-16"
}
},
"productid": "0078-0694_8c405b95-6d3c-4bc5-9b01-2feb80903756",
"productndc": "0078-0694",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211225",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "001",
"approval_date": "Mar 18, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CERITINIB",
"proprietary_name": "ZYKADIA",
"active_ingred_unit": "mg/1",
"application_number": "NDA211225",
"marketing_category": "NDA",
"nonproprietary_name": "ceritinib",
"start_marketing_date": "20190318",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code L01ED02.
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