Vivitrol Kit
NDC Package 65757-301-01

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

Package Information

Vivitrol (naltrexone) kits is a medication used to treat alcohol abuse. This formulation utilizes a kit delivery system. Marketed by Alkermes, Inc., this product is identified by NDC 65757-301 and is authorized under FDA application NDA021897.

Identification & Billing

NDC Package Code
65757-301-01
Package Description
1 KIT in 1 CARTON * 4 mL in 1 VIAL, GLASS (65757-303-02) * 4 mL in 1 VIAL, GLASS (65757-305-03)
Product Code
65757-301
11-Digit Billing Format
65757030101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vivitrol
Non-Proprietary Name
Naltrexone
Dosage Form
Kit - A packaged collection of related material.
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).

Regulatory & Marketing

Labeler Name
Alkermes, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021897
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-13-2006
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 65757-301-01 identifies a specific commercial package of 1 kit in 1 carton * 4 ml in 1 vial, glass (65757-303-02) * 4 ml in 1 vial, glass (65757-305-03) of Vivitrol, a human prescription drug labeled by Alkermes, Inc.. This kit is formulated for use and contains 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 Alkermes, Inc. on June 13, 2006. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65757030101. 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)
65757-301-01
11-Digit CMS (5-4-2)
65757-0301-01

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