Narcan Spray
NDC Package 69547-627-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Narcan (naloxone hydrochloride nasal) sprays is a medication used for the emergency treatment of known or suspected opioid overdose. This formulation utilizes a spray delivery system. Marketed by Emergent Devices Inc., this product is identified by NDC 69547-627 and is authorized under FDA application NDA208411.

Identification & Billing

NDC Package Code
69547-627-06
Package Description
6 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
11-Digit Billing Format
69547062706
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Narcan
Non-Proprietary Name
Naloxone Hydrochloride Nasal
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)
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
Emergent Devices Inc.
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
12-31-2027
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 (69547-627). Click a package code to view its specific billing and regulatory data.

2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE
1 CASE in 1 CARTON / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSE
24 VIAL, SINGLE-DOSE in 1 CARTON / .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 69547-627-06 identifies a specific commercial package of 6 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose of Narcan, a human over the counter drug labeled by Emergent Devices Inc.. 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 Emergent Devices Inc. on August 28, 2023. The current certification is valid through December 31, 2027.

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 Emergent Devices Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69547062706. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
69547-627-06
11-Digit CMS (5-4-2)
69547-0627-06

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