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United States · US · US:67184-0533_a41dbedd-ee4e-401c-b446-a435929ff903
imatinib mesylate
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11671840533130 TABLET in 1 BOTTLE (67184-0533-1)
- ndc116718405332300 TABLET in 1 BOTTLE (67184-0533-2)
- ndc11671840533330 BLISTER PACK in 1 CARTON (67184-0533-3) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A212135
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": "67184-0533_a41dbedd-ee4e-401c-b446-a435929ff903",
"productndc": "67184-0533",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212135",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Jun 21, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 400MG BASE",
"product_no": "002",
"approval_date": "Jun 21, 2022"
}
],
"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": "ANDA212135",
"marketing_category": "ANDA",
"nonproprietary_name": "imatinib mesylate",
"start_marketing_date": "20220621",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L01EA01.
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