🇺🇸
United States · US · US:82448-260_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
- ndc11824482604242 CAPSULE in 1 BOTTLE (82448-260-42)
- ndc11824482608484 CAPSULE in 1 BOTTLE (82448-260-84)
Annotations
UNII (FDA Substance ID)
86K0J5AK6M
MIRDAMETINIB
Orange Book
N219389
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": "82448-260_849abb0f-1b19-4b4f-a3fe-113869a59653",
"productndc": "82448-260",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "219389",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "1MG",
"product_no": "001",
"approval_date": "Feb 11, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG",
"product_no": "002",
"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": "NDA219389",
"marketing_category": "NDA",
"nonproprietary_name": "mirdametinib",
"start_marketing_date": "20250211",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01EE05.
Access this data programmatically
Query Gomekli and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.