OJEMDA

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDay One Biopharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8295001201
1 KIT in 1 CARTON (82950-012-01) * 12 mL in 1 BOTTLE, GLASS (82950-112-10)

Annotations

Orange Book

N218033

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "82950-012_8bee41f8-a2d9-44ae-82a9-bd46b6f9916a",
  "productndc": "82950-012",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "218033",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Apr 23, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "OJEMDA",
  "active_ingred_unit": null,
  "application_number": "NDA218033",
  "marketing_category": "NDA",
  "nonproprietary_name": "tovorafenib",
  "start_marketing_date": "20240430",
  "active_numerator_strength": null
}

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