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  5. NDC Package Code: 65757-300-01 Vivitrol

NDC Package 65757-300-01 Vivitrol

Naltrexone Kit - 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:
65757-300-01
Package Description:
1 KIT in 1 CARTON * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)
Product Code:
65757-300
Proprietary Name:
Vivitrol
Non-Proprietary Name:
Naltrexone
Usage Information:
This medication is used to treat alcohol abuse. It is used only in people who have been able to stop drinking for some time before starting treatment with naltrexone. You should not be drinking when you start naltrexone. It can help people drink less alcohol or stop drinking altogether. Naltrexone works in the brain to decrease the desire to drink. It does not work like some other treatments for alcohol abuse (e.g., disulfiram). It will not make you sick when taken with alcohol. This medication is also used to prevent relapse to opioid abuse, after opioid detoxification. It works by blocking the action of opioids. This medication must not be used in people currently taking opiates, including methadone. Doing so can cause sudden withdrawal symptoms. Naltrexone belongs to a class of drugs known as opiate antagonists. It is used as part of a complete treatment program for alcohol or opioid abuse (e.g., counseling, 12-step program, lifestyle changes).
11-Digit NDC Billing Format:
65757030001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 637213 - naltrexone 380 MG Injection
  • RxCUI: 637216 - Vivitrol 380 MG Injection
  • RxCUI: 637216 - naltrexone 380 MG Injection [Vivitrol]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alkermes, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA021897
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-13-2006
    Listing Expiration Date:
    12-31-2024
    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 65757-300-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    65757030001J2315Naltrexone, depot form1 MG11380380

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65757-300-01?

    The NDC Packaged Code 65757-300-01 is assigned to a package of 1 kit in 1 carton * 4 ml in 1 vial, glass (65757-302-02) * 4 ml in 1 vial, glass (65757-304-03) of Vivitrol, a human prescription drug labeled by Alkermes, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 65757-300 included in the NDC Directory?

    Yes, Vivitrol with product code 65757-300 is active and included in the NDC Directory. The product was first marketed by Alkermes, Inc. on June 13, 2006 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65757-300-01?

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

    What is the 11-digit format for NDC 65757-300-01?

    The 11-digit format is 65757030001. 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
    5-3-265757-300-015-4-265757-0300-01