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United States · US · US:0310-0625_bdebc47d-8420-42eb-aaa7-b243dc9e42b2
KOSELUGO
Orange BookUNIISPLATC L01EE04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL01EE04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11031006252828 CAPSULE in 1 BOTTLE (0310-0625-28)
- ndc11031006256060 CAPSULE in 1 BOTTLE (0310-0625-60)
Annotations
UNII (FDA Substance ID)
6UH91I579U
SELUMETINIB
RxCUI 2289380
Orange Book
N213756
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6UH91I579U",
"rxcui": "2289380",
"inchikey": "CYOHGALHFOKKQC-UHFFFAOYSA-N",
"display_name": "SELUMETINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7d042c61-f28f-4ab5-ab10-d7558c0d49ff": {
"match": "brand_token",
"title": "KOSELUGO (SELUMETINIB) CAPSULE KOSELUGO (SELUMETINIB) GRANULE [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "17",
"published_date": "2026-06-01"
}
},
"productid": "0310-0625_bdebc47d-8420-42eb-aaa7-b243dc9e42b2",
"productndc": "0310-0625",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213756",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Apr 10, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Apr 10, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SELUMETINIB",
"proprietary_name": "KOSELUGO",
"active_ingred_unit": "mg/1",
"application_number": "NDA213756",
"marketing_category": "NDA",
"nonproprietary_name": "SELUMETINIB",
"start_marketing_date": "20200416",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01EE04.
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