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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
- ndc1180739812121 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE
- ndc1180739812181 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.
- PLKrazatiBristol-Myers Squibb Pharma EEIG
- ISKrazatiBristol-Myers Squibb Pharma EEIG
- CZKRAZATIBristol-Myers Squibb Pharma EEIG, Dublin
- CZKRAZATIBristol-Myers Squibb Pharma EEIG, Dublin
- FIKRAZATIBristol-Myers Squibb Pharma EEIG
- DKKRAZATIBristol-Myers Squibb Pharma EEIG
- BEKrazati 200 mgBristol-Myers Squibb Pharma
- IEKRAZATI 200 mg film-coated tabletsBristol-Myers Squibb Pharma EEIG
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