Herceptin
NDC Package 50242-333-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Herceptin is trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called HER2 protein. Marketed by Genentech, Inc., this product is identified by NDC 50242-333 and is authorized under FDA application BLA103792.

Identification & Billing

NDC Package Code
50242-333-01
Package Description
1 KIT in 1 CARTON * 20 mL in 1 VIAL, MULTI-DOSE * 20 mL in 1 VIAL
Product Code
50242-333
11-Digit Billing Format
50242033301

Clinical Specifications

Proprietary Name
Herceptin
Dosage Form
-
Usage Information
Trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called HER2 protein. Trastuzumab belongs to a class of medications known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. This monograph is about the following trastuzumab products: trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
FDA Application #
BLA103792
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-25-1998
End Marketing Date
02-03-2021
Listing Expiration
02-03-2021
Exclude Flag
D
Sample Package
No

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 50242-333-01 identifies a specific commercial package of 1 kit in 1 carton * 20 ml in 1 vial, multi-dose * 20 ml in 1 vial of Herceptin, labeled by Genentech, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Genentech, Inc. on September 25, 1998. The current certification is valid through February 03, 2021.

What are the primary indications for this medication?

Trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called HER2 protein. Trastuzumab belongs to a class of medications known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. This monograph is about the following trastuzumab products: trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp.

How is this Genentech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242033301. 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 (5-3-2)
50242-333-01
11-Digit CMS (5-4-2)
50242-0333-01

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