Polatuzumab Vedotin Liquid
NDC Package 50242-430-01

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

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.

Polatuzumab Vedotin liquids is a drug for further processing. This formulation utilizes a liquid delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-430.

Identification & Billing

NDC Package Code
50242-430-01
Package Description
120 L in 1 TANK
Product Code
50242-430
11-Digit Billing Format
50242043001

Clinical Specifications

Proprietary Name
Polatuzumab Vedotin
Non-Proprietary Name
Polatuzumab Vedotin
Substance Name
Polatuzumab Vedotin
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)
POLATUZUMAB VEDOTIN 50 mg/.001L

Regulatory & Marketing

Labeler Name
Genentech, 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
06-10-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50242-430). Click a package code to view its specific billing and regulatory data.

50242-430-02
300 L in 1 TANK

* 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 50242-430-01 identifies a specific commercial package of 120 l in 1 tank of Polatuzumab Vedotin (UNFINISHED drug), drug for further processing labeled by Genentech, Inc.. This liquid is formulated for use and contains polatuzumab vedotin 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 June 10, 2019. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242043001. 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)
50242-430-01
11-Digit CMS (5-4-2)
50242-0430-01

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