Naltrexone
NDC Package 69364-3143-6

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.

Naltrexone is treatment with naltrexone implants should be part of a comprehensive management program that includes psychological and psychosocial support.Naltrexone tablets were initially approved by the FDA in 1985 for the treatment of abuse and addiction of opioids.Naltrexone in oral and extended release injection forms have been approved by the FDA for the treatment and abuse of alcohol.Naltrexone implants may be useful for the treatment of alcohol or opioid dependence in patients who are able to abstain from opioid or alcohol in an outpatient setting prior to initiation of treatment.Patients should not be actively drinking or be on any opioids at the time of initial naltrexone implant administration. Marketed by Complete Pharmacy And Medical Solutions, this product is identified by NDC 69364-3143.

Identification & Billing

NDC Package Code
69364-3143-6
Package Description
6 BLISTER PACK in 1 BOX / 1 IMPLANT in 1 BLISTER PACK
Product Code
69364-3143
11-Digit Billing Format
69364314306
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA

Clinical Specifications

Proprietary Name
Naltrexone
Dosage Form
-
Usage Information
Treatment with naltrexone implants should be part of a comprehensive management program that includes psychological and psychosocial support.Naltrexone tablets were initially approved by the FDA in 1985 for the treatment of abuse and addiction of opioids.Naltrexone in oral and extended release injection forms have been approved by the FDA for the treatment and abuse of alcohol.Naltrexone implants may be useful for the treatment of alcohol or opioid dependence in patients who are able to abstain from opioid or alcohol in an outpatient setting prior to initiation of treatment.Patients should not be actively drinking or be on any opioids at the time of initial naltrexone implant administration.

Regulatory & Marketing

Labeler Name
Complete Pharmacy And Medical Solutions
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
02-01-2018
Listing Expiration
12-31-2019
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 69364-3143-6 identifies a specific commercial package of 6 blister pack in 1 box / 1 implant in 1 blister pack of Naltrexone, labeled by Complete Pharmacy And Medical Solutions. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. 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 Complete Pharmacy And Medical Solutions on February 01, 2018. The current certification is valid through December 31, 2019.

How is this Complete Pharmacy And Medical Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69364314306. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 total billable units per package. 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)
69364-3143-6
11-Digit CMS (5-4-2)
69364-3143-06

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