Komzifti

Orange BookUNIISPL

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

Identification

ManufacturerKura Oncology, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8469620090
90 CAPSULE in 1 BOTTLE (84696-200-90)

Annotations

UNII (FDA Substance ID)

4MOD1F4ENC

ZIFTOMENIB

Orange Book

N220305

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4MOD1F4ENC",
    "rxcui": null,
    "inchikey": "BGGALFIXXQOTPY-NRFANRHFSA-N",
    "display_name": "ZIFTOMENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b650f696-3391-4274-8b55-a5f5e9d04769": {
      "match": "brand_token",
      "title": "KOMZIFTI (ZIFTOMENIB) CAPSULE [KURA ONCOLOGY, INC.]",
      "spl_version": "1",
      "published_date": "2025-12-16"
    }
  },
  "productid": "84696-200_3213879b-dd88-413b-9910-8fd422c99805",
  "productndc": "84696-200",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "220305",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Nov 13, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIFTOMENIB",
  "proprietary_name": "Komzifti",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA220305",
  "marketing_category": "NDA",
  "nonproprietary_name": "ziftomenib",
  "start_marketing_date": "20251113",
  "active_numerator_strength": "200"
}

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