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United States · US · US:0078-1490_cbc7561e-5e16-4e05-9c07-52626c43eafc
Gleevec
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100781490133 BLISTER PACK in 1 CARTON (0078-1490-13) / 10 TABLET in 1 BLISTER PACK (0078-1490-26)
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
N021588
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": {
"211ef2da-2868-4a77-8055-1cb2cd78e24b": {
"match": "brand_token",
"title": "GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "40",
"published_date": "2026-02-19"
}
},
"productid": "0078-1490_cbc7561e-5e16-4e05-9c07-52626c43eafc",
"productndc": "0078-1490",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021588",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Apr 18, 2003"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 400MG BASE",
"product_no": "002",
"approval_date": "Apr 18, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMATINIB MESYLATE",
"proprietary_name": "Gleevec",
"active_ingred_unit": "mg/1",
"application_number": "NDA021588",
"marketing_category": "NDA",
"nonproprietary_name": "imatinib mesylate",
"start_marketing_date": "20141223",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L01EA01.
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