Gazyva Injection, Solution, Concentrate
NDC Package 50242-070-86

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

Gazyva (obinutuzumab) injection is obinutuzumab is used to treat certain types of blood cancer (such as chronic lymphocytic leukemia, follicular lymphoma). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-070 and is authorized under FDA application BLA125486.

Identification & Billing

NDC Package Code
50242-070-86
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 40 mL in 1 VIAL, SINGLE-USE
Product Code
50242-070
11-Digit Billing Format
50242007086
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gazyva
Non-Proprietary Name
Obinutuzumab
Substance Name
Obinutuzumab
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
OBINUTUZUMAB 1000 mg/40mL
Pharmacologic Class
Usage Information
Obinutuzumab is used to treat certain types of blood cancer (such as chronic lymphocytic leukemia, follicular lymphoma). Obinutuzumab belongs to a class of drugs known as monoclonal antibodies. It works by stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125486
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-01-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (50242-070). Click a package code to view its specific billing and regulatory data.

50242-070-01
1 VIAL, SINGLE-USE in 1 CARTON / 40 mL in 1 VIAL, SINGLE-USE

* 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 50242-070-86 identifies a specific commercial package of 1 vial, single-use in 1 carton / 40 ml in 1 vial, single-use of Gazyva, a human prescription drug labeled by Genentech, Inc.. This injection, solution, concentrate is formulated for intravenous use and contains obinutuzumab 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 Genentech, Inc. on November 01, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Obinutuzumab is used to treat certain types of blood cancer (such as chronic lymphocytic leukemia, follicular lymphoma). Obinutuzumab belongs to a class of drugs known as monoclonal antibodies. It works by stopping the growth of cancer cells.

How is this Genentech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242007086. 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 (5-3-2)
50242-070-86
11-Digit CMS (5-4-2)
50242-0070-86

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