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United States · US · US:82009-087_92ab5711-1241-43d8-9e2c-47c973ca0cc1
Imatinib Mesylate
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQUALLENT PHARMACEUTICALS HEALTH LLC
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11820090873030 TABLET, FILM COATED in 1 BOTTLE (82009-087-30)
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A212773
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": "82009-087_92ab5711-1241-43d8-9e2c-47c973ca0cc1",
"productndc": "82009-087",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212773",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Jul 23, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 400MG BASE",
"product_no": "002",
"approval_date": "Jul 23, 2020"
}
],
"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": "ANDA212773",
"marketing_category": "ANDA",
"nonproprietary_name": "Imatinib Mesylate",
"start_marketing_date": "20230901",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L01EA01.
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