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United States · US · US:42388-024_e8cdcbdc-d863-4d48-af3e-a8926b9ab017
CABOMETYX
Orange BookUNIISPLATC L01EX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExelixis, Inc.
CountryUS (United States)
ATC codeL01EX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11423880242630 TABLET in 1 BOTTLE (42388-024-26)
- ndc11423880243715 TABLET in 1 BOTTLE (42388-024-37)
- ndc1142388024461 BOTTLE in 1 CARTON (42388-024-46) / 30 TABLET in 1 BOTTLE
- ndc1142388024571 BOTTLE in 1 CARTON (42388-024-57) / 15 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
DR7ST46X58
CABOZANTINIB S-MALATE
RxCUI 1363267
Orange Book
N208692
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DR7ST46X58",
"rxcui": "1363267",
"inchikey": "HFCFMRYTXDINDK-WNQIDUERSA-N",
"display_name": "CABOZANTINIB S-MALATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3850cce2-6137-42e5-a792-d318c4a4b3b5": {
"match": "brand_token",
"title": "CABOMETYX (CABOZANTINIB) TABLET [EXELIXIS, INC.]",
"spl_version": "18",
"published_date": "2025-11-17"
}
},
"productid": "42388-024_e8cdcbdc-d863-4d48-af3e-a8926b9ab017",
"productndc": "42388-024",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208692",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Apr 25, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Apr 25, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "003",
"approval_date": "Apr 25, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CABOZANTINIB S-MALATE",
"proprietary_name": "CABOMETYX",
"active_ingred_unit": "mg/1",
"application_number": "NDA208692",
"marketing_category": "NDA",
"nonproprietary_name": "cabozantinib",
"start_marketing_date": "20160425",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L01EX07.
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