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United States · US · US:0597-9257_e6b8d0ba-dbfa-4104-bb8a-3c574d097056
HERNEXEOS
Orange BookUNIISPLATC L01EH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1105979257591 BOTTLE, PLASTIC in 1 CARTON (0597-9257-59) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1105979257861 BOTTLE, PLASTIC in 1 CARTON (0597-9257-86) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
DRH7R67UVL
ZONGERTINIB
Orange Book
N219042
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DRH7R67UVL",
"rxcui": null,
"inchikey": "YSGNGFPNTLERCR-UHFFFAOYSA-N",
"display_name": "ZONGERTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d3fabf12-354e-4e5c-b5de-20fdb579b783": {
"match": "brand_token",
"title": "HERNEXEOS (ZONGERTINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "6",
"published_date": "2026-04-09"
}
},
"productid": "0597-9257_e6b8d0ba-dbfa-4104-bb8a-3c574d097056",
"productndc": "0597-9257",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219042",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "60MG",
"product_no": "001",
"approval_date": "Aug 8, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZONGERTINIB",
"proprietary_name": "HERNEXEOS",
"active_ingred_unit": "mg/1",
"application_number": "NDA219042",
"marketing_category": "NDA",
"nonproprietary_name": "zongertinib",
"start_marketing_date": "20250808",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code L01EH.
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