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United States · US · US:0378-2245_a88e0c38-cbf6-4e41-af11-623228830c34
Imatinib Mesylate
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037822457790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77)
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A204644
ABAB
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": "0378-2245_a88e0c38-cbf6-4e41-af11-623228830c34",
"productndc": "0378-2245",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204644",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Jun 21, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 400MG BASE",
"product_no": "002",
"approval_date": "Jun 21, 2017"
}
],
"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": "ANDA204644",
"marketing_category": "ANDA",
"nonproprietary_name": "imatinib",
"start_marketing_date": "20170928",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EA01.
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