Campral
NDC Package 68151-4760-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Campral is ® is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Marketed by Carilion Materials Management, this product is identified by NDC 68151-4760 and is authorized under FDA application NDA021431.

Identification & Billing

NDC Package Code
68151-4760-0
Package Description
1 TABLET, DELAYED RELEASE in 1 PACKAGE
Product Code
68151-4760
11-Digit Billing Format
68151476000
RxNorm Crosswalk
  • RxCUI: 835726 - acamprosate calcium 333 MG Delayed Release Oral Tablet
  • RxCUI: 835726 - acamprosate calcium 333 MG (acamprosate 300 MG) Delayed Release Oral Tablet
  • RxCUI: 835728 - Campral 333 MG Delayed Release Oral Tablet
  • RxCUI: 835728 - acamprosate calcium 333 MG Delayed Release Oral Tablet [Campral]
  • RxCUI: 835728 - Campral 333 MG (equivalent to acamprosate 300 MG) Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Campral
Dosage Form
-
Usage Information
Campral® is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.The efficacy of Campral in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral treatment. The efficacy of Campral in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

Regulatory & Marketing

Labeler Name
Carilion Materials Management
FDA Application #
NDA021431
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-11-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 68151-4760-0 identifies a specific commercial package of 1 tablet, delayed release in 1 package of Campral, labeled by Carilion Materials Management. 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 Carilion Materials Management on January 11, 2005. The current certification is valid through December 31, 2017.

How is this Carilion Materials Management product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68151476000. 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 (5-4-1)
68151-4760-0
11-Digit CMS (5-4-2)
68151-4760-00

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