Ofatumumab Liquid
NDC Package 0078-1539-09

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 Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1539.

Identification & Billing

NDC Package Code
0078-1539-09
Package Description
2 kg in 1 BOTTLE
Product Code
0078-1539
11-Digit Billing Format
00078153909

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 1 kg/kg
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
Novartis Pharmaceuticals Corporation
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-20-2020
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 0078-1539-09 identifies a specific commercial package of 2 kg in 1 bottle of Ofatumumab (UNFINISHED drug), a bulk ingredient labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on August 20, 2020. The current certification is valid through December 31, 2027.

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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078153909. 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 (4-4-2)
0078-1539-09
11-Digit CMS (5-4-2)
00078-1539-09

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