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United States · US · US:50419-390_0e3ba6e7-af8d-4840-9409-a537a09e1263
VITRAKVI
Orange BookUNIISPLATC L01EX12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01EX12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11504193900160 CAPSULE in 1 BOTTLE (50419-390-01)
Annotations
UNII (FDA Substance ID)
PF9462I9HX
LAROTRECTINIB
RxCUI 2105628
Orange Book
N210861
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "PF9462I9HX",
"rxcui": "2105628",
"inchikey": "NYNZQNWKBKUAII-KBXCAEBGSA-N",
"display_name": "LAROTRECTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0c8ca614-58b2-4aa4-83d3-0387a8f782fd": {
"match": "brand_token",
"title": "VITRAKVI (LAROTRECTINIB) CAPSULE VITRAKVI (LAROTRECTINIB) SOLUTION, CONCENTRATE [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "21",
"published_date": "2026-05-25"
}
},
"productid": "50419-390_0e3ba6e7-af8d-4840-9409-a537a09e1263",
"productndc": "50419-390",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210861",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 26, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Nov 26, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAROTRECTINIB",
"proprietary_name": "VITRAKVI",
"active_ingred_unit": "mg/1",
"application_number": "NDA210861",
"marketing_category": "NDA",
"nonproprietary_name": "LAROTRECTINIB",
"start_marketing_date": "20190726",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01EX12.
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