Naltrexone Hydrochloride Tablet, Film Coated
NDC Package 53401-008-31

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 Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 53401-008 and is authorized under FDA application ANDA075274.

Identification & Billing

NDC Package Code
53401-008-31
Package Description
600 TABLET, FILM COATED in 1 BOTTLE
Product Code
53401-008
11-Digit Billing Format
53401000831
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
600 EA
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
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-26-2015
End Marketing Date
06-30-2028
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 53401-008-31 identifies a specific commercial package of 600 tablet, film coated in 1 bottle of Naltrexone Hydrochloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 600 billable units per package. 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 Aphena Pharma Solutions - Tennessee, Llc on March 26, 2015.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53401000831. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 600 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 (5-3-2)
53401-008-31
11-Digit CMS (5-4-2)
53401-0008-31

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