Narcan Spray
NDC Package 71205-528-02

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

Package Information

Narcan (naloxone hydrochloride) sprays is a medication used for the emergency treatment of known or suspected opioid overdose. This formulation utilizes a spray delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 71205-528 and is authorized under FDA application NDA208411.

Identification & Billing

NDC Package Code
71205-528-02
Package Description
2 VIAL, SINGLE-DOSE in 1 PACKAGE / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
71205-528
11-Digit Billing Format
71205052802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Narcan
Non-Proprietary Name
Naloxone Hydrochloride
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 for the emergency treatment of known or suspected opioid overdose. Serious opioid 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. This medication 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. The effects of naloxone will not last as long as the effects of the opioid. Since treatment with this medication is not long lasting, be sure to get medical help right away after giving the first 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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
NDA208411
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-24-2017
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 71205-528-02 identifies a specific commercial package of 2 vial, single-dose in 1 package / .1 ml in 1 vial, single-dose of Narcan, a human prescription drug labeled by Proficient Rx Lp. 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 Proficient Rx Lp on January 24, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used for the emergency treatment of known or suspected opioid overdose. Serious opioid 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. This medication 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. The effects of naloxone will not last as long as the effects of the opioid. Since treatment with this medication is not long lasting, be sure to get medical help right away after giving the first 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 Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71205052802. 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)
71205-528-02
11-Digit CMS (5-4-2)
71205-0528-02

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