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United States · US · US:0310-0635_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 · 1
- ndc11031006356060 GRANULE in 1 BOTTLE (0310-0635-60)
Annotations
UNII (FDA Substance ID)
6UH91I579U
SELUMETINIB
RxCUI 2289380
Orange Book
N219943
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": "0310-0635_bdebc47d-8420-42eb-aaa7-b243dc9e42b2",
"productndc": "0310-0635",
"dosage_form": "GRANULE",
"orange_book": {
"appl_no": "219943",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Sep 10, 2025"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 7.5MG BASE",
"product_no": "002",
"approval_date": "Sep 10, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SELUMETINIB",
"proprietary_name": "KOSELUGO",
"active_ingred_unit": "mg/1",
"application_number": "NDA219943",
"marketing_category": "NDA",
"nonproprietary_name": "SELUMETINIB",
"start_marketing_date": "20250910",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01EE04.
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