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United States · US · US:50242-717_f3881f36-9b41-4c3c-a964-f7a3ecc932d1
Cotellic
Orange BookUNIISPLATC L01EE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01EE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502427170163 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)
Annotations
UNII (FDA Substance ID)
6EXI96H8SV
COBIMETINIB FUMARATE
RxCUI 1722380
Orange Book
N206192
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6EXI96H8SV",
"rxcui": "1722380",
"inchikey": "RESIMIUSNACMNW-BXRWSSRYSA-N",
"display_name": "COBIMETINIB FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c387579e-cee0-4334-bd1e-73f93ac1bde6": {
"match": "brand_token",
"title": "COTELLIC (COBIMETINIB) TABLET, FILM COATED [GENENTECH, INC.]",
"spl_version": "23",
"published_date": "2025-12-04"
}
},
"productid": "50242-717_f3881f36-9b41-4c3c-a964-f7a3ecc932d1",
"productndc": "50242-717",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206192",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Nov 10, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COBIMETINIB FUMARATE",
"proprietary_name": "Cotellic",
"active_ingred_unit": "mg/1",
"application_number": "NDA206192",
"marketing_category": "NDA",
"nonproprietary_name": "COBIMETINIB",
"start_marketing_date": "20151110",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L01EE02.
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