Arzerra
NDC Package 0078-0669-13

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

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

Arzerra is ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0669 and is authorized under FDA application BLA125326.

Identification & Billing

NDC Package Code
0078-0669-13
Package Description
3 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)
Product Code
0078-0669
11-Digit Billing Format
00078066913
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Arzerra
Dosage Form
-
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
FDA Application #
BLA125326
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-01-2016
End Marketing Date
03-31-2026
Listing Expiration
03-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9302
Source: OPPS
Ofatumumab injection
HCPCS Dosage 10 MG
Units / Pkg 30

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0078-0669-13 identifies a specific commercial package of 3 vial, single-use in 1 carton / 5 ml in 1 vial, single-use (0078-0669-61) of Arzerra, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on February 01, 2016. The current certification is valid through March 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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078066913. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0078-0669-13
11-Digit CMS (5-4-2)
00078-0669-13

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