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United States · US · US:80739-812_65724d4c-78ab-4d85-83b5-73b9da5c2cc3

KRAZATI

Orange BookUNIISPLATC L01XX77

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMirati Therapeutics, Inc
CountryUS (United States)
ATC codeL01XX77
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8073981212
    1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE
  • ndc11
    8073981218
    1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
8EOO6HQF8Y
ADAGRASIB
Orange Book
N216340
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8EOO6HQF8Y",
    "rxcui": null,
    "inchikey": "PEMUGDMSUDYLHU-ZEQRLZLVSA-N",
    "display_name": "ADAGRASIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0b8bf078-34c2-4f45-9012-38a8ac082b01": {
      "match": "brand_token",
      "title": "KRAZATI (ADAGRASIB) TABLET, COATED [MIRATI THERAPEUTICS, INC]",
      "spl_version": "13",
      "published_date": "2026-04-02"
    }
  },
  "productid": "80739-812_65724d4c-78ab-4d85-83b5-73b9da5c2cc3",
  "productndc": "80739-812",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "216340",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Dec 12, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ADAGRASIB",
  "proprietary_name": "KRAZATI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216340",
  "marketing_category": "NDA",
  "nonproprietary_name": "adagrasib",
  "start_marketing_date": "20221212",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code L01XX77.

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