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  5. NDC Package Code: 64764-300-20 Entyvio

NDC Package 64764-300-20 Entyvio

Vedolizumab Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
64764-300-20
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
64764-300
Proprietary Name:
Entyvio
Non-Proprietary Name:
Vedolizumab
Substance Name:
Vedolizumab
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.
11-Digit NDC Billing Format:
64764030020
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
Product Type:
Human Prescription Drug
Labeler Name:
Takeda Pharmaceuticals America, Inc.
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.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • VEDOLIZUMAB 300 mg/5mL
    • Pharmacologic Class(es):
  • Integrin Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Integrin Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA125476
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-20-2014
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 64764-300-20 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    64764030020J3380Injection, vedolizumab1 MG11300300

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64764-300-20?

    The NDC Packaged Code 64764-300-20 is assigned to a package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Entyvio, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 64764-300 included in the NDC Directory?

    Yes, Entyvio with product code 64764-300 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on May 20, 2014 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 64764-300-20?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 64764-300-20?

    The 11-digit format is 64764030020. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-264764-300-205-4-264764-0300-20