🇺🇸
United States · US · US:50242-091_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 · 2
- ndc1150242091301 BOTTLE in 1 CARTON (50242-091-30) / 30 CAPSULE in 1 BOTTLE
- ndc1150242091861 BOTTLE in 1 CARTON (50242-091-86) / 30 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
L5ORF0AN1I
ENTRECTINIB
RxCUI 2197862
Orange Book
N212725
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": "50242-091_b93e1fc0-614a-4e49-a91d-a409fb2db9f0",
"productndc": "50242-091",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212725",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 15, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Aug 15, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTRECTINIB",
"proprietary_name": "Rozlytrek",
"active_ingred_unit": "mg/1",
"application_number": "NDA212725",
"marketing_category": "NDA",
"nonproprietary_name": "ENTRECTINIB",
"start_marketing_date": "20190815",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EX14.
Access this data programmatically
Query Rozlytrek 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.