Naltrexone Hydrochloride Tablet, Film Coated
NDC Package 68071-3654-3

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

Package Information

Naltrexone Hydrochloride tablets is uSP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. This formulation utilizes a tablet, film coated delivery system. Marketed by Nucare Pharmaceuticals Inc., this product is identified by NDC 68071-3654 and is authorized under FDA application ANDA075274.

Identification & Billing

NDC Package Code
68071-3654-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-3654
11-Digit Billing Format
68071365403
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naltrexone Hydrochloride
Non-Proprietary Name
Naltrexone Hydrochloride
Substance Name
Naltrexone Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NALTREXONE HYDROCHLORIDE 50 mg/1
Pharmacologic Class
Usage Information
Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.Naltrexone Hydrochloride Tablets USP have 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 Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-15-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 68071-3654-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Naltrexone Hydrochloride, a human prescription drug labeled by Nucare Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains naltrexone hydrochloride 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 Nucare Pharmaceuticals Inc. on February 15, 2024. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071365403. 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)
68071-3654-3
11-Digit CMS (5-4-2)
68071-3654-03

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