Ofatumumab Liquid
NDC Package 67643-0016-2

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.

Ofatumumab liquids is ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). This formulation utilizes a liquid delivery system. Marketed by Lonza Biologics Inc., this product is identified by NDC 67643-0016.

Identification & Billing

NDC Package Code
67643-0016-2
Package Description
13500 mL in 1 BAG
Product Code
67643-0016
11-Digit Billing Format
67643001602

Clinical Specifications

Proprietary Name
Ofatumumab
Non-Proprietary Name
Ofatumumab
Substance Name
Ofatumumab
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)
OFATUMUMAB 121 mg/mL
Usage Information
Ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). Ofatumumab belongs to a class of drugs known as monoclonal antibodies. This medication works by stopping the growth of 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
04-01-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67643-0016-2 identifies a specific commercial package of 13500 ml in 1 bag of Ofatumumab (UNFINISHED drug), drug for further processing labeled by Lonza Biologics Inc.. This liquid is formulated for use and contains ofatumumab 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 April 01, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). Ofatumumab belongs to a class of drugs known as monoclonal antibodies. This medication works by stopping the growth of 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: 67643001602. 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)
67643-0016-2
11-Digit CMS (5-4-2)
67643-0016-02

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