Pertuzumab Liquid
NDC Package 67643-7002-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Pertuzumab liquids is pertuzumab is used to treat certain types of breast cancer. This formulation utilizes a liquid delivery system. Marketed by Lonza Biologics, Inc., this product is identified by NDC 67643-7002.

Identification & Billing

NDC Package Code
67643-7002-2
Package Description
300000 mL in 1 TANK
Product Code
67643-7002
11-Digit Billing Format
67643700202

Clinical Specifications

Proprietary Name
Pertuzumab
Non-Proprietary Name
Pertuzumab
Substance Name
Pertuzumab
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
PERTUZUMAB 33 mg/mL
Usage Information
Pertuzumab is used to treat certain types of breast cancer. It is also used to treat early stage breast cancer in patients who will be having surgery to remove the cancer. The types of cancers pertuzumab is used to treat are tumors that produce more than the normal amount of a certain substance called HER2 protein. This medication is called a monoclonal antibody. It works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.

Regulatory & Marketing

Labeler Name
Lonza Biologics, Inc.
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
06-08-2012
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67643-7002). Click a package code to view its specific billing and regulatory data.

67643-7002-1
120000 mL in 1 TANK

* 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 67643-7002-2 identifies a specific commercial package of 300000 ml in 1 tank of Pertuzumab (UNFINISHED drug), drug for further processing labeled by Lonza Biologics, Inc.. This liquid is formulated for use and contains pertuzumab 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 Lonza Biologics, Inc. on June 08, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pertuzumab is used to treat certain types of breast cancer. It is also used to treat early stage breast cancer in patients who will be having surgery to remove the cancer. The types of cancers pertuzumab is used to treat are tumors that produce more than the normal amount of a certain substance called HER2 protein. This medication is called a monoclonal antibody. It works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67643700202. 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)
67643-7002-2
11-Digit CMS (5-4-2)
67643-7002-02

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