NDC Package 0078-0669-13 Arzerra

Ofatumumab Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
Arzerra
Non-Proprietary Name:
Ofatumumab
Substance Name:
Ofatumumab
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.
11-Digit NDC Billing Format:
00078066913
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1658042 - ofatumumab 1000 MG in 50 ML Injection
  • RxCUI: 1658042 - 50 ML ofatumumab 20 MG/ML Injection
  • RxCUI: 1658042 - ofatumumab 1000 MG per 50 ML Injection
  • RxCUI: 1658044 - Arzerra 1000 MG in 50 ML Injection
  • RxCUI: 1658044 - 50 ML ofatumumab 20 MG/ML Injection [Arzerra]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125326
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-01-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0078-0669-13 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00078066913J9302Ofatumumab injection10 MG531030

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0669-13?

    The NDC Packaged Code 0078-0669-13 is assigned to a package of 3 vial, single-use in 1 carton / 5 ml in 1 vial, single-use (0078-0669-61) of Arzerra, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0078-0669 included in the NDC Directory?

    Yes, Arzerra with product code 0078-0669 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on February 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-0669-13?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0078-0669-13?

    The 11-digit format is 00078066913. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20078-0669-135-4-200078-0669-13