Cetuximab Liquid
NDC Package 73424-0561-2

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.

Cetuximab liquids is cetuximab is used to treat a certain type of cancer of the colon (large intestine) or rectum. This formulation utilizes a liquid delivery system. Marketed by Celltrion Branchburg, Llc, this product is identified by NDC 73424-0561.

Identification & Billing

NDC Package Code
73424-0561-2
Package Description
1 BAG in 1 TANK / 204 kg in 1 BAG
Product Code
73424-0561
11-Digit Billing Format
73424056102

Clinical Specifications

Proprietary Name
Cetuximab
Non-Proprietary Name
Cetuximab
Substance Name
Cetuximab
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)
CETUXIMAB 1 kg/kg
Usage Information
Cetuximab is used to treat a certain type of cancer of the colon (large intestine) or rectum. This medication is also used to treat head and neck cancer. Cetuximab works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors. Cetuximab is a man-made protein (monoclonal antibody).

Regulatory & Marketing

Labeler Name
Celltrion Branchburg, Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-12-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (73424-0561). Click a package code to view its specific billing and regulatory data.

73424-0561-1
1 BAG in 1 TANK / 102 kg in 1 BAG

* 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 73424-0561-2 identifies a specific commercial package of 1 bag in 1 tank / 204 kg in 1 bag of Cetuximab (UNFINISHED drug), a bulk ingredient labeled by Celltrion Branchburg, Llc. This liquid is formulated for use and contains cetuximab 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 Celltrion Branchburg, Llc on February 12, 2004. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Cetuximab is used to treat a certain type of cancer of the colon (large intestine) or rectum. This medication is also used to treat head and neck cancer. Cetuximab works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors. Cetuximab is a man-made protein (monoclonal antibody).

How is this Celltrion Branchburg, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73424056102. 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)
73424-0561-2
11-Digit CMS (5-4-2)
73424-0561-02

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