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United States · US · US:0069-0136_ca8600d9-46e6-402d-89f9-bc6a156bf751
BOSULIF
Orange BookUNIISPLATC L01EA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeL01EA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006901360130 TABLET, FILM COATED in 1 BOTTLE (0069-0136-01)
Annotations
UNII (FDA Substance ID)
844ZJE6I55
BOSUTINIB MONOHYDRATE
RxCUI 1314319
Orange Book
N203341
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "844ZJE6I55",
"rxcui": "1314319",
"inchikey": "BXPOSPOKHGNMEP-UHFFFAOYSA-N",
"display_name": "BOSUTINIB MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d5929f91-6496-4c0e-97e8-0bd524e15763": {
"match": "brand_token",
"title": "BOSULIF (BOSUTINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
"spl_version": "6",
"published_date": "2026-05-29"
}
},
"productid": "0069-0136_ca8600d9-46e6-402d-89f9-bc6a156bf751",
"productndc": "0069-0136",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203341",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Sep 4, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "Sep 4, 2012"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 400MG BASE",
"product_no": "003",
"approval_date": "Oct 27, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BOSUTINIB MONOHYDRATE",
"proprietary_name": "BOSULIF",
"active_ingred_unit": "mg/1",
"application_number": "NDA203341",
"marketing_category": "NDA",
"nonproprietary_name": "Bosutinib",
"start_marketing_date": "20120904",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code L01EA04.
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