Vedolizumab Iv Liquid
NDC Package 67643-0023-2

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.

Vedolizumab Iv liquids is a medication used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). This formulation utilizes a liquid delivery system. Marketed by Lonza Biologics, Inc., this product is identified by NDC 67643-0023.

Identification & Billing

NDC Package Code
67643-0023-2
Package Description
1800 mL in 1 BOTTLE
Product Code
67643-0023
11-Digit Billing Format
67643002302

Clinical Specifications

Proprietary Name
Vedolizumab Iv
Non-Proprietary Name
Vedolizumab Iv
Substance Name
Vedolizumab
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)
VEDOLIZUMAB 105 mg/mL
Usage Information
This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.

Regulatory & Marketing

Labeler Name
Lonza Biologics, 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
04-06-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67643-0023-2 identifies a specific commercial package of 1800 ml in 1 bottle of Vedolizumab Iv (UNFINISHED drug), drug for further processing labeled by Lonza Biologics, Inc.. This liquid is formulated for use and contains vedolizumab 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 Lonza Biologics, Inc. on April 06, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). In these conditions, the body's defense system (immune system) attacks healthy tissues in the gut, causing symptoms such as abdominal pain, blood in the stool, and diarrhea. Vedolizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the actions of a certain natural substance (integrin) in the body. This helps to decrease swelling (inflammation) in the gut, which lessens symptoms and may slow or stop damage from these bowel disorders.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67643002302. 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 (5-4-1)
67643-0023-2
11-Digit CMS (5-4-2)
67643-0023-02

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