Zongertinib Film-coated Tablets, 60 Mg Tablet, Coated
NDC Package 50909-2002-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Zongertinib Film-coated Tablets, 60 Mg tablets is a drug for further processing. This formulation utilizes a tablet, coated delivery system. Marketed by Hovione Farmaciencia Sa, this product is identified by NDC 50909-2002.

Identification & Billing

NDC Package Code
50909-2002-1
Package Description
1 BAG in 1 DRUM / 12500 TABLET, COATED in 1 BAG
Product Code
50909-2002
11-Digit Billing Format
50909200201

Clinical Specifications

Proprietary Name
Zongertinib Film-coated Tablets, 60 Mg
Non-Proprietary Name
Zongertinib Film-coated Tablets, 60 Mg
Substance Name
Zongertinib
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Active Ingredient(s)
ZONGERTINIB 60 mg/1

Regulatory & Marketing

Labeler Name
Hovione Farmaciencia Sa
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
08-16-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50909-2002-1 identifies a specific commercial package of 1 bag in 1 drum / 12500 tablet, coated in 1 bag of Zongertinib Film-coated Tablets, 60 Mg (UNFINISHED drug), drug for further processing labeled by Hovione Farmaciencia Sa. This tablet, coated is formulated for use and contains zongertinib as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hovione Farmaciencia Sa on August 16, 2025. The current certification is valid through December 31, 2027.

How is this Hovione Farmaciencia Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50909200201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
50909-2002-1
11-Digit CMS (5-4-2)
50909-2002-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.