Vedolizumab Injection, Powder, Lyophilized, For Solution
NDC Package 11532-3002-1

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 injection is a medication used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Takeda Pharmaceutical Company Limited, this product is identified by NDC 11532-3002.

Identification & Billing

NDC Package Code
11532-3002-1
Package Description
400 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Product Code
11532-3002
11-Digit Billing Format
11532300201

Clinical Specifications

Proprietary Name
Vedolizumab
Non-Proprietary Name
Vedolizumab
Substance Name
Vedolizumab
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Active Ingredient(s)
VEDOLIZUMAB 300 mg/1
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
Takeda Pharmaceutical Company Limited
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
05-20-2014
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 11532-3002-1 identifies a specific commercial package of 400 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial of Vedolizumab (UNFINISHED drug), drug for further processing labeled by Takeda Pharmaceutical Company Limited. This injection, powder, lyophilized, for solution 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 Takeda Pharmaceutical Company Limited on May 20, 2014. 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 Takeda Pharmaceutical Company Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11532300201. 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)
11532-3002-1
11-Digit CMS (5-4-2)
11532-3002-01

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