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  5. NDC Package Code: 60842-002-02 Naloxone Hydrochloride Injection, Usp, Auto-injector

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

Naloxone Hydrochloride Injection, Solution Intramuscular; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
60842-002-02
Package Description:
10 DOSE PACK in 1 CARTON / .4 mL in 1 DOSE PACK
Product Code:
60842-002
Proprietary Name:
Naloxone Hydrochloride Injection, Usp, Auto-injector
Non-Proprietary Name:
Naloxone Hydrochloride
Substance Name:
Naloxone Hydrochloride
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.
11-Digit NDC Billing Format:
60842000202
NDC to RxNorm Crosswalk:
  • RxCUI: 2596175 - naloxone HCl 10 MG in 0.4 ML Auto-Injector
  • RxCUI: 2596175 - 0.4 ML naloxone hydrochloride 25 MG/ML Auto-Injector
  • RxCUI: 2596175 - naloxone HCl 10 MG per 0.4 ML Auto-Injector
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Kaleo, Inc.
    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(s):
  • 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(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA215457
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-28-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 60842-002-02?

    The NDC Packaged Code 60842-002-02 is assigned to a 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.. The product's dosage form is injection, solution and is administered via intramuscular; subcutaneous form.

    Is NDC 60842-002 included in the NDC Directory?

    Yes, Naloxone Hydrochloride Injection, Usp, Auto-injector with product code 60842-002 is active and included in the NDC Directory. The product was first marketed by Kaleo, Inc. on February 28, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 60842-002-02?

    The 11-digit format is 60842000202. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-260842-002-025-4-260842-0002-02