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United States · US · US:57894-080_da4a9239-16d7-46cf-b089-e943e0080015
LAZCLUZE
Orange BookUNIISPLATC L01EB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC codeL01EB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157894080601 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE
- ndc1157894080901 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4A2Y23XK11
LAZERTINIB
Orange Book
N219008
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4A2Y23XK11",
"rxcui": null,
"inchikey": "RRMJMHOQSALEJJ-UHFFFAOYSA-N",
"display_name": "LAZERTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c417f9ee-2027-4ed5-92ad-3c19266de16c": {
"match": "brand_token",
"title": "LAZCLUZE (LAZERTINIB) TABLET, FILM COATED [JANSSEN BIOTECH, INC.]",
"spl_version": "6",
"published_date": "2026-05-07"
}
},
"productid": "57894-080_da4a9239-16d7-46cf-b089-e943e0080015",
"productndc": "57894-080",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219008",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 80MG BASE",
"product_no": "001",
"approval_date": "Aug 19, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 240MG BASE",
"product_no": "002",
"approval_date": "Aug 19, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAZERTINIB",
"proprietary_name": "LAZCLUZE",
"active_ingred_unit": "mg/1",
"application_number": "NDA219008",
"marketing_category": "NDA",
"nonproprietary_name": "lazertinib",
"start_marketing_date": "20240820",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code L01EB09.
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