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United States · US · US:47335-475_ad13dbca-474d-4492-9c25-e0e175143d8c
imatinib mesylate
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114733547513500 TABLET, FILM COATED in 1 BOTTLE (47335-475-13)
- ndc1147335475643 BLISTER PACK in 1 CARTON (47335-475-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11473354758330 TABLET, FILM COATED in 1 BOTTLE (47335-475-83)
- ndc114733547588100 TABLET, FILM COATED in 1 BOTTLE (47335-475-88)
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": "47335-475_ad13dbca-474d-4492-9c25-e0e175143d8c",
"productndc": "47335-475",
"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": "20160201",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L01EA01.
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