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United States · US · US:43598-345_38a9944b-db90-72f2-3f0b-7767da490ae2
Imatinib
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Inc
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114359834505500 TABLET in 1 CONTAINER (43598-345-05)
- ndc11435983453030 TABLET in 1 CONTAINER (43598-345-30)
- ndc1143598345313 BLISTER PACK in 1 CARTON (43598-345-31) / 10 TABLET in 1 BLISTER PACK
- ndc11435983459090 TABLET in 1 CONTAINER (43598-345-90)
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
A206547
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": "43598-345_38a9944b-db90-72f2-3f0b-7767da490ae2",
"productndc": "43598-345",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206547",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Aug 13, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 400MG BASE",
"product_no": "002",
"approval_date": "Aug 13, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMATINIB MESYLATE",
"proprietary_name": "Imatinib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206547",
"marketing_category": "ANDA",
"nonproprietary_name": "Imatinib",
"start_marketing_date": "20180813",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L01EA01.
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