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United States · US · US:46708-312_17a3b455-b49a-492d-b6dc-47e96e6037ed
Bosutinib
Orange BookUNIISPLATC L01EA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeL01EA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11467083123030 TABLET, FILM COATED in 1 BOTTLE (46708-312-30)
Annotations
UNII (FDA Substance ID)
5018V4AEZ0
BOSUTINIB
RxCUI 1307619
Orange Book
A209543
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5018V4AEZ0",
"rxcui": "1307619",
"inchikey": "UBPYILGKFZZVDX-UHFFFAOYSA-N",
"display_name": "BOSUTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2ea1617f-41d3-479a-87d5-177013d39193": {
"match": "brand_token",
"title": "BOSUTINIB TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]",
"spl_version": "20",
"published_date": "2026-05-25"
}
},
"productid": "46708-312_17a3b455-b49a-492d-b6dc-47e96e6037ed",
"productndc": "46708-312",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209543",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "May 23, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "002",
"approval_date": "May 23, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BOSUTINIB",
"proprietary_name": "Bosutinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209543",
"marketing_category": "ANDA",
"nonproprietary_name": "Bosutinib",
"start_marketing_date": "20260519",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code L01EA04.
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