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United States · US · US:50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864
ZELBORAF
Orange BookUNIISPLATC L01EC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01EC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150242090021 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
207SMY3FQT
VEMURAFENIB
RxCUI 1147220
Orange Book
N202429
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "207SMY3FQT",
"rxcui": "1147220",
"inchikey": "GPXBXXGIAQBQNI-UHFFFAOYSA-N",
"display_name": "VEMURAFENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"38eea320-7e0c-485a-bc30-98c3c45e2763": {
"match": "brand_token",
"title": "ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]",
"spl_version": "28",
"published_date": "2025-12-10"
}
},
"productid": "50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864",
"productndc": "50242-090",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202429",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "240MG",
"product_no": "001",
"approval_date": "Aug 17, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VEMURAFENIB",
"proprietary_name": "ZELBORAF",
"active_ingred_unit": "mg/1",
"application_number": "NDA202429",
"marketing_category": "NDA",
"nonproprietary_name": "Vemurafenib",
"start_marketing_date": "20110817",
"active_numerator_strength": "240"
}Related drugs
Other records sharing ATC code L01EC01.
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