Naltrexone Hydrochloride
NDC Package 68071-2721-3

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 Hydrochloride is tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.Naltrexone hydrochloride tablets USP 50 mg has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. Marketed by Nucare Pharmceuticals,inc., this product is identified by NDC 68071-2721 and is authorized under FDA application ANDA091205.

Identification & Billing

NDC Package Code
68071-2721-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-2721
11-Digit Billing Format
68071272103
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naltrexone Hydrochloride
Dosage Form
-
Usage Information
Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.Naltrexone hydrochloride tablets USP 50 mg has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

Regulatory & Marketing

Labeler Name
Nucare Pharmceuticals,inc.
FDA Application #
ANDA091205
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-18-2012
Listing Expiration
12-31-2024
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 68071-2721-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Naltrexone Hydrochloride, labeled by Nucare Pharmceuticals,inc.. 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 Nucare Pharmceuticals,inc. on January 18, 2012. The current certification is valid through December 31, 2024.

How is this Nucare Pharmceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071272103. 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)
68071-2721-3
11-Digit CMS (5-4-2)
68071-2721-03

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