Naloxone Hcl Spray
NDC Package 51662-1620-2

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

Package Information

Naloxone Hcl sprays is a medication used to treat known or suspected opioid overdose. This formulation utilizes a spray delivery system. Marketed by Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1620 and is authorized under FDA application ANDA211951.

Identification & Billing

NDC Package Code
51662-1620-2
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
51662-1620
11-Digit Billing Format
51662162002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naloxone Hcl
Non-Proprietary Name
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
This medication is used to treat known or suspected opioid overdose. Serious overdose symptoms may include unusual sleepiness, unusual difficulty waking up, or breathing problems (ranging from slow/shallow breathing to no breathing). Other symptoms of overdose may include very small "pinpoint" pupils, slow heartbeat, or low blood pressure. If someone has serious overdose symptoms but you are not sure if he or she has overdosed, give this medication right away anyway, since lasting slow/shallow breathing may cause permanent damage to the brain or death. Naloxone belongs to a class of drugs known as opioid antagonists. It works by blocking the effects of the opioid in the brain. This medication may not work as well to block the effects of certain types of opioids (mixed agonist/antagonists such as buprenorphine, pentazocine). With these types of opioids, blocking may be incomplete or you may need a higher dose of naloxone. Treatment of opioid overdose should also include breathing treatment (such as oxygen given through tubes in the nose, mechanical ventilation, artificial respiration).

Regulatory & Marketing

Labeler Name
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Prescription Drug
FDA Application #
ANDA211951
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-10-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51662-1620). Click a package code to view its specific billing and regulatory data.

51662-1620-1
.1 mL in 1 VIAL, SINGLE-DOSE

* 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 51662-1620-2 identifies a specific commercial package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose of Naloxone Hcl, a human prescription 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 April 10, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat known or suspected opioid overdose. Serious overdose symptoms may include unusual sleepiness, unusual difficulty waking up, or breathing problems (ranging from slow/shallow breathing to no breathing). Other symptoms of overdose may include very small "pinpoint" pupils, slow heartbeat, or low blood pressure. If someone has serious overdose symptoms but you are not sure if he or she has overdosed, give this medication right away anyway, since lasting slow/shallow breathing may cause permanent damage to the brain or death. Naloxone belongs to a class of drugs known as opioid antagonists. It works by blocking the effects of the opioid in the brain. This medication may not work as well to block the effects of certain types of opioids (mixed agonist/antagonists such as buprenorphine, pentazocine). With these types of opioids, blocking may be incomplete or you may need a higher dose of naloxone. Treatment of opioid overdose should also include breathing treatment (such as oxygen given through tubes in the nose, mechanical ventilation, artificial respiration).

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: 51662162002. 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)
51662-1620-2
11-Digit CMS (5-4-2)
51662-1620-02

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