Naloxone Hydrochloride Injection, Usp, Auto-injector Injection, Solution
NDC Package 60842-002-02

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

Package Information

Naloxone Hydrochloride Injection, Usp, Auto-injector (naloxone hydrochloride) injection is nALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. This formulation utilizes a injection, solution delivery system. Marketed by Kaleo, Inc., this product is identified by NDC 60842-002 and is authorized under FDA application NDA215457.

Identification & Billing

NDC Package Code
60842-002-02
Package Description
10 DOSE PACK in 1 CARTON / .4 mL in 1 DOSE PACK
Product Code
60842-002
11-Digit Billing Format
60842000202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naloxone Hydrochloride Injection, Usp, Auto-injector
Non-Proprietary Name
Naloxone Hydrochloride
Substance Name
Naloxone Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
NALOXONE HYDROCHLORIDE 10 mg/.4mL
Pharmacologic Class
Usage Information
NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

Regulatory & Marketing

Labeler Name
Kaleo, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215457
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-28-2022
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 60842-002-02 identifies a specific commercial package of 10 dose pack in 1 carton / .4 ml in 1 dose pack of Naloxone Hydrochloride Injection, Usp, Auto-injector, a human prescription drug labeled by Kaleo, Inc.. This injection, solution is formulated for intramuscular; subcutaneous use and contains naloxone 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 Kaleo, Inc. on February 28, 2022. The current certification is valid through December 31, 2026.

How is this Kaleo, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60842000202. 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)
60842-002-02
11-Digit CMS (5-4-2)
60842-0002-02

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