Entyvio Injection, Solution
NDC Package 64764-107-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Entyvio (vedolizumab) injection is a medication used to treat certain bowel disorders (ulcerative colitis, Crohn's disease). This formulation utilizes a injection, solution delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-107 and is authorized under FDA application BLA761133.

Identification & Billing

NDC Package Code
64764-107-11
Package Description
1 TRAY in 1 CARTON / 1 SYRINGE in 1 TRAY (64764-107-10) / .68 mL in 1 SYRINGE
Product Code
64764-107
11-Digit Billing Format
64764010711
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Entyvio
Non-Proprietary Name
Vedolizumab
Substance Name
Vedolizumab
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
VEDOLIZUMAB 108 mg/.68mL
Pharmacologic Class
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 Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761133
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-27-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 64764-107-11 identifies a specific commercial package of 1 tray in 1 carton / 1 syringe in 1 tray (64764-107-10) / .68 ml in 1 syringe of Entyvio, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This injection, solution is formulated for subcutaneous 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 Pharmaceuticals America, Inc. on September 27, 2023. The current certification is valid through December 31, 2027.

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 Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764010711. 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)
64764-107-11
11-Digit CMS (5-4-2)
64764-0107-11

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