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United States · US · US:42388-013_03fee098-20c7-4a04-81a7-06fb7d8b1470
COMETRIQ
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 · 1
- ndc1142388013144 BLISTER PACK in 1 CARTON (42388-013-14) / 21 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
DR7ST46X58
CABOZANTINIB S-MALATE
RxCUI 1363267
Orange Book
N203756
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": {
"1a0c3bea-c87b-4d25-bb44-5f0174da6b34": {
"match": "brand_token",
"title": "COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]",
"spl_version": "16",
"published_date": "2025-11-17"
}
},
"productid": "42388-013_03fee098-20c7-4a04-81a7-06fb7d8b1470",
"productndc": "42388-013",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203756",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Nov 29, 2012"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 80MG BASE",
"product_no": "002",
"approval_date": "Nov 29, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CABOZANTINIB S-MALATE",
"proprietary_name": "COMETRIQ",
"active_ingred_unit": "mg/1",
"application_number": "NDA203756",
"marketing_category": "NDA",
"nonproprietary_name": "cabozantinib",
"start_marketing_date": "20121129",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L01EX07.
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