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United States · US · US:50242-623_b93e1fc0-614a-4e49-a91d-a409fb2db9f0
Rozlytrek
Orange BookUNIISPLATC L01EX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01EX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502426234242 DOSE PACK in 1 CARTON (50242-623-42) / 20 PELLET in 1 DOSE PACK (50242-623-01)
Annotations
UNII (FDA Substance ID)
L5ORF0AN1I
ENTRECTINIB
RxCUI 2197862
Orange Book
N218550
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L5ORF0AN1I",
"rxcui": "2197862",
"inchikey": "HAYYBYPASCDWEQ-UHFFFAOYSA-N",
"display_name": "ENTRECTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c7c71b0c-2549-4495-86b6-c2807fa54908": {
"match": "brand_token",
"title": "ROZLYTREK (ENTRECTINIB) CAPSULE ROZLYTREK (ENTRECTINIB) PELLET [GENENTECH, INC.]",
"spl_version": "18",
"published_date": "2025-12-10"
}
},
"productid": "50242-623_b93e1fc0-614a-4e49-a91d-a409fb2db9f0",
"productndc": "50242-623",
"dosage_form": "PELLET",
"orange_book": {
"appl_no": "218550",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/PACKET",
"product_no": "001",
"approval_date": "Oct 20, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTRECTINIB",
"proprietary_name": "Rozlytrek",
"active_ingred_unit": "mg/201",
"application_number": "NDA218550",
"marketing_category": "NDA",
"nonproprietary_name": "ENTRECTINIB",
"start_marketing_date": "20231020",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01EX14.
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