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United States · US · US:63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727
Lorbrena
Orange BookUNIISPLATC L01ED05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerU.S. Pharmaceuticals
CountryUS (United States)
ATC codeL01ED05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11635399270130 TABLET, FILM COATED in 1 BOTTLE (63539-927-01)
Annotations
UNII (FDA Substance ID)
OSP71S83EU
LORLATINIB
RxCUI 2103164
Orange Book
N210868
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "OSP71S83EU",
"rxcui": "2103164",
"inchikey": "IIXWYSCJSQVBQM-LLVKDONJSA-N",
"display_name": "LORLATINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"004f93d7-a1cd-4b67-9207-31cdcb5c5976": {
"match": "brand_token",
"title": "LORBRENA (LORLATINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
"spl_version": "3",
"published_date": "2026-02-18"
}
},
"productid": "63539-927_810ce789-bff1-42b9-aef7-1f92f0dde727",
"productndc": "63539-927",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210868",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Nov 2, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Nov 2, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LORLATINIB",
"proprietary_name": "Lorbrena",
"active_ingred_unit": "mg/1",
"application_number": "NDA210868",
"marketing_category": "NDA",
"nonproprietary_name": "lorlatinib",
"start_marketing_date": "20230103",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L01ED05.
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