Narcan Naloxone Hcl Spray
NDC Package 51662-1642-2

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

Package Information

Narcan Naloxone Hcl sprays is for opioid emergencies, call 911. This formulation utilizes a spray delivery system. Marketed by Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1642 and is authorized under FDA application NDA208411.

Identification & Billing

NDC Package Code
51662-1642-2
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE (51662-1642-1)
Product Code
51662-1642
11-Digit Billing Format
51662164202

Clinical Specifications

Proprietary Name
Narcan Naloxone Hcl
Non-Proprietary Name
Narcan Naloxone Hcl
Substance Name
Naloxone Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
NALOXONE HYDROCHLORIDE 4 mg/.1mL
Pharmacologic Class
Usage Information
For opioid emergencies, call 911. For questions on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM. ©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries.Other Information• store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) • do not freeze • avoid excessive heat above 40°C (104°F) • protect from light • the product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.

Regulatory & Marketing

Labeler Name
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Otc Drug
FDA Application #
NDA208411
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-28-2023
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 51662-1642-2 identifies a specific commercial package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose (51662-1642-1) of Narcan Naloxone Hcl, a human over the counter drug labeled by Hf Acquisition Co Llc, Dba Healthfirst. This spray is formulated for nasal 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 Hf Acquisition Co Llc, Dba Healthfirst on August 28, 2023. The current certification is valid through December 31, 2026.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662164202. 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)
51662-1642-2
11-Digit CMS (5-4-2)
51662-1642-02

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