hernexeos

Generic: zongertinib

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hernexeos
Generic Name zongertinib
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

zongertinib 60 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-9257
Product ID 0597-9257_4eb81210-2a15-494d-8157-1899dfcd4fd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219042
Listing Expiration 2026-12-31
Marketing Start 2025-08-08

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
her2/neu/cerbb2 antagonists [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05979257
Hyphenated Format 0597-9257

Supplemental Identifiers

RxCUI
2721609 2721615
UNII
DRH7R67UVL
NUI
N0000175605 N0000020008 N0000190113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hernexeos (source: ndc)
Generic Name zongertinib (source: ndc)
Application Number NDA219042 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CARTON in 1 BOTTLE, PLASTIC (0597-9257-59) / 1 TABLET, FILM COATED in 1 CARTON
  • 60 CARTON in 1 BOTTLE, PLASTIC (0597-9257-86) / 1 TABLET, FILM COATED in 1 CARTON
source: ndc

Packages (2)

0597-9257-59 30 CARTON in 1 BOTTLE, PLASTIC (0597-9257-59) / 1 TABLET, FILM COATED in 1 CARTON 0597-9257-86 60 CARTON in 1 BOTTLE, PLASTIC (0597-9257-86) / 1 TABLET, FILM COATED in 1 CARTON

Ingredients (1)

zongertinib (60 mg/1)

Linked Drug Pages (1)

HERNEXEOS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4eb81210-2a15-494d-8157-1899dfcd4fd3", "openfda": {"nui": ["N0000175605", "N0000020008", "N0000190113"], "unii": ["DRH7R67UVL"], "rxcui": ["2721609", "2721615"], "spl_set_id": ["d3fabf12-354e-4e5c-b5de-20fdb579b783"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CARTON in 1 BOTTLE, PLASTIC (0597-9257-59)  / 1 TABLET, FILM COATED in 1 CARTON", "package_ndc": "0597-9257-59", "marketing_start_date": "20260106"}, {"sample": false, "description": "60 CARTON in 1 BOTTLE, PLASTIC (0597-9257-86)  / 1 TABLET, FILM COATED in 1 CARTON", "package_ndc": "0597-9257-86", "marketing_start_date": "20250808"}], "brand_name": "HERNEXEOS", "product_id": "0597-9257_4eb81210-2a15-494d-8157-1899dfcd4fd3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "HER2/Neu/cerbB2 Antagonists [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "0597-9257", "generic_name": "zongertinib", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HERNEXEOS", "active_ingredients": [{"name": "ZONGERTINIB", "strength": "60 mg/1"}], "application_number": "NDA219042", "marketing_category": "NDA", "marketing_start_date": "20250808", "listing_expiration_date": "20261231"}