Back to search
🇺🇸

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

  • ndc11
    8295000116
    4 BLISTER PACK in 1 CARTON (82950-001-16) / 4 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-04)
  • ndc11
    8295000120
    4 BLISTER PACK in 1 CARTON (82950-001-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-05)
  • ndc11
    8295000124
    4 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

Query OJEMDA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.