Naltrexone Kit
NDC Package 69238-2794-1

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

Package Information

Naltrexone kits is treatment with naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support. This formulation utilizes a kit delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2794 and is authorized under FDA application NDA021897.

Identification & Billing

NDC Package Code
69238-2794-1
Package Description
1 KIT in 1 CARTON * 5 mL in 1 VIAL, GLASS (69238-2792-1) * 4 mL in 1 VIAL, GLASS (69238-2793-1)
Product Code
69238-2794
11-Digit Billing Format
69238279401
RxNorm Crosswalk
RxCUI: 637213 - naltrexone 380 MG Injection

Clinical Specifications

Proprietary Name
Naltrexone
Non-Proprietary Name
Naltrexone
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Treatment with naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021897
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2026
Listing Expiration
12-31-2027
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 69238-2794-1 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 vial, glass (69238-2792-1) * 4 ml in 1 vial, glass (69238-2793-1) of Naltrexone, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This kit is formulated for use and contains 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 Amneal Pharmaceuticals Ny Llc on May 01, 2026. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238279401. 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)
69238-2794-1
11-Digit CMS (5-4-2)
69238-2794-01

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