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United States · US · US:82950-001_8bee41f8-a2d9-44ae-82a9-bd46b6f9916a
OJEMDA
Orange BookUNIISPLATC L01EC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDay One Biopharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1182950001164 BLISTER PACK in 1 CARTON (82950-001-16) / 4 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-04)
- ndc1182950001204 BLISTER PACK in 1 CARTON (82950-001-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-05)
- ndc1182950001244 BLISTER PACK in 1 CARTON (82950-001-24) / 6 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-06)
Annotations
UNII (FDA Substance ID)
ZN90E4027M
TOVORAFENIB
Orange Book
N217700
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ZN90E4027M",
"rxcui": null,
"inchikey": "VWMJHAFYPMOMGF-ZCFIWIBFSA-N",
"display_name": "TOVORAFENIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ea3a9631-3a66-6a7c-e053-2995a90ae2ad": {
"match": "brand_token",
"title": "OJEMDA (TOVORAFENIB) KIT OJEMDA (TOVORAFENIB) TABLET, FILM COATED [DAY ONE BIOPHARMACEUTICALS, INC.]",
"spl_version": "9",
"published_date": "2025-09-08"
}
},
"productid": "82950-001_8bee41f8-a2d9-44ae-82a9-bd46b6f9916a",
"productndc": "82950-001",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217700",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Apr 23, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOVORAFENIB",
"proprietary_name": "OJEMDA",
"active_ingred_unit": "mg/1",
"application_number": "NDA217700",
"marketing_category": "NDA",
"nonproprietary_name": "TOVORAFENIB",
"start_marketing_date": "20240430",
"active_numerator_strength": "100"
}Access this data programmatically
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