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United States · US · US:82448-134_849abb0f-1b19-4b4f-a3fe-113869a59653
Gomekli
Orange BookUNIISPLATC L01EE05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpringWorks Therapeutics, Inc.
CountryUS (United States)
ATC codeL01EE05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11824481344242 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-42)
- ndc11824481348484 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-84)
Annotations
UNII (FDA Substance ID)
86K0J5AK6M
MIRDAMETINIB
Orange Book
N219379
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "86K0J5AK6M",
"rxcui": null,
"inchikey": "SUDAHWBOROXANE-SECBINFHSA-N",
"display_name": "MIRDAMETINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4c41bf90-5fa7-4935-a95c-e047ea6bbf8e": {
"match": "brand_token",
"title": "GOMEKLI (MIRDAMETINIB) CAPSULE GOMEKLI (MIRDAMETINIB) TABLET, FOR SUSPENSION [SPRINGWORKS THERAPEUTICS, INC.]",
"spl_version": "6",
"published_date": "2026-05-15"
}
},
"productid": "82448-134_849abb0f-1b19-4b4f-a3fe-113869a59653",
"productndc": "82448-134",
"dosage_form": "TABLET, FOR SUSPENSION",
"orange_book": {
"appl_no": "219379",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG",
"product_no": "001",
"approval_date": "Feb 11, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIRDAMETINIB",
"proprietary_name": "Gomekli",
"active_ingred_unit": "mg/1",
"application_number": "NDA219379",
"marketing_category": "NDA",
"nonproprietary_name": "mirdametinib",
"start_marketing_date": "20250211",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01EE05.
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