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United States · US · US:0069-8141_f5e01d3a-43fc-4fa6-b5dd-a07330b49328
Xalkori
Orange BookUNIISPLATC L01ED01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeL01ED01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006981412060 CAPSULE in 1 BOTTLE (0069-8141-20)
Annotations
UNII (FDA Substance ID)
53AH36668S
CRIZOTINIB
RxCUI 1148495
Orange Book
N202570
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "53AH36668S",
"rxcui": "1148495",
"inchikey": "KTEIFNKAUNYNJU-GFCCVEGCSA-N",
"display_name": "CRIZOTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2a51b0de-47d6-455e-a94c-d2c737b04ff7": {
"match": "brand_token",
"title": "XALKORI (CRIZOTINIB) CAPSULE XALKORI (CRIZOTINIB) CAPSULE, COATED PELLETS [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "46",
"published_date": "2025-07-24"
}
},
"productid": "0069-8141_f5e01d3a-43fc-4fa6-b5dd-a07330b49328",
"productndc": "0069-8141",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202570",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Aug 26, 2011"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "250MG",
"product_no": "002",
"approval_date": "Aug 26, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CRIZOTINIB",
"proprietary_name": "Xalkori",
"active_ingred_unit": "mg/1",
"application_number": "NDA202570",
"marketing_category": "NDA",
"nonproprietary_name": "CRIZOTINIB",
"start_marketing_date": "20110826",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L01ED01.
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