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United States · US · US:0069-0298_e850e390-b32e-4382-a2c7-d480c41bd3a6
Daurismo
Orange BookUNIISPLATC L01XJ03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeL01XJ03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006902986060 TABLET, FILM COATED in 1 BOTTLE (0069-0298-60)
Annotations
UNII (FDA Substance ID)
K673DMO5H9
GLASDEGIB
RxCUI 2105845
Orange Book
N210656
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K673DMO5H9",
"rxcui": "2105845",
"inchikey": "SFNSLLSYNZWZQG-VQIMIIECSA-N",
"display_name": "GLASDEGIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"204a6f7e-c9a4-472b-abd2-9527bda64d17": {
"match": "brand_token",
"title": "DAURISMO (GLASDEGIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "11",
"published_date": "2025-12-12"
}
},
"productid": "0069-0298_e850e390-b32e-4382-a2c7-d480c41bd3a6",
"productndc": "0069-0298",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210656",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 21, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Nov 21, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLASDEGIB",
"proprietary_name": "Daurismo",
"active_ingred_unit": "mg/1",
"application_number": "NDA210656",
"marketing_category": "NDA",
"nonproprietary_name": "glasdegib",
"start_marketing_date": "20181210",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01XJ03.
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