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  5. NDC Package Code: 0597-9257-86 Hernexeos

NDC Package 0597-9257-86 Hernexeos

Zongertinib Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0597-9257-86
Package Description:
60 CARTON in 1 BOTTLE, PLASTIC / 1 TABLET, FILM COATED in 1 CARTON
Product Code:
0597-9257
Proprietary Name:
Hernexeos
Non-Proprietary Name:
Zongertinib
Substance Name:
Zongertinib
Usage Information:
HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy [see Dosage and Administration (2.1)].This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
11-Digit NDC Billing Format:
00597925786
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Boehringer Ingelheim Pharmaceuticals, Inc.
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
ZONGERTINIB 60 mg/1
Sample Package:
No
FDA Application Number:
NDA219042
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-08-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0597-9257-86?

The NDC Packaged Code 0597-9257-86 is assigned to a package of 60 carton in 1 bottle, plastic / 1 tablet, film coated in 1 carton of Hernexeos, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0597-9257 included in the NDC Directory?

Yes, Hernexeos with product code 0597-9257 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on August 08, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0597-9257-86?

The 11-digit format is 00597925786. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20597-9257-865-4-200597-9257-86