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United States · US · US:81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc
IMKELDI
Orange BookUNIISPLATC L01EA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerShorla Oncology Inc.,
CountryUS (United States)
ATC codeL01EA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118192720101140 mL in 1 BOTTLE (81927-201-01)
Annotations
UNII (FDA Substance ID)
8A1O1M485B
IMATINIB MESYLATE
RxCUI 284924
Orange Book
N219097
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": {
"26658bb7-9ba1-a10e-e063-6394a90a172e": {
"match": "brand_token",
"title": "IMKELDI (IMATINIB ORAL) SOLUTION [SHORLA ONCOLOGY INC.,]",
"spl_version": "2",
"published_date": "2024-12-20"
}
},
"productid": "81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc",
"productndc": "81927-201",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219097",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 80MG BASE/ML",
"product_no": "001",
"approval_date": "Nov 22, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMATINIB MESYLATE",
"proprietary_name": "IMKELDI",
"active_ingred_unit": "mg/mL",
"application_number": "NDA219097",
"marketing_category": "NDA",
"nonproprietary_name": "imatinib oral",
"start_marketing_date": "20241219",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code L01EA01.
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