Vivitrol
NDC Package 63459-300-42

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Vivitrol is a medication used to treat alcohol abuse. Marketed by Cephalon, this product is identified by NDC 63459-300 and is authorized under FDA application NDA021897.

Identification & Billing

NDC Package Code
63459-300-42
Package Description
1 KIT in 1 CARTON * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-USE (63459-310-04) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (63459-300-38)
Product Code
11-Digit Billing Format
63459030042

Clinical Specifications

Proprietary Name
Vivitrol
Dosage Form
-
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
Cephalon
FDA Application #
NDA021897
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-13-2006
End Marketing Date
12-31-2009
Listing Expiration
12-31-2009
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage
  • 63459 - Cephalon
    • 63459-300 - Vivitrol
      • 63459-300-42 - 1 KIT in 1 CARTON * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-USE (63459-310-04) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (63459-300-38)

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 63459-300-42 identifies a specific commercial package of 1 kit in 1 carton * 1 injection, solution in 1 vial, single-use (63459-310-04) * 1 injection, powder, for suspension, extended release in 1 vial, single-dose (63459-300-38) of Vivitrol, labeled by Cephalon. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Cephalon on June 13, 2006. The current certification is valid through December 31, 2009.

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 Cephalon product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63459030042. 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)
63459-300-42
11-Digit CMS (5-4-2)
63459-0300-42

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