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United States · US · US:68001-491_05c9d227-d639-916a-e063-6294a90a66a6
imatinib mesylate
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680014910430 TABLET, FILM COATED in 1 BOTTLE (68001-491-04)
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A078340
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8A1O1M485B",
"rxcui": "284924",
"inchikey": "YLMAHDNUQAMNNX-UHFFFAOYSA-N",
"display_name": "IMATINIB MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c0611fc0-b217-4988-acd4-b8c629ce489b": {
"match": "brand_token",
"title": "IMATINIB MESYLATE TABLET, FILM COATED [BLUEPOINT LABORATORIES]",
"spl_version": "4",
"published_date": "2026-05-25"
}
},
"productid": "68001-491_05c9d227-d639-916a-e063-6294a90a66a6",
"productndc": "68001-491",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078340",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Dec 3, 2015"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 400MG BASE",
"product_no": "002",
"approval_date": "Dec 3, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMATINIB MESYLATE",
"proprietary_name": "imatinib mesylate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078340",
"marketing_category": "ANDA",
"nonproprietary_name": "imatinib mesylate",
"start_marketing_date": "20210326",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L01EA01.
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