Rextovy Spray
NDC Package 76329-3669-2

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

Package Information

Rextovy (naloxone hydrochloride) sprays is naloxone Hydrochloride Nasal Spray is indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.Naloxone Hydrochloride Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.Naloxone Hydrochloride Nasal Spray is not a substitute for emergency medical care. This formulation utilizes a spray delivery system. Marketed by International Medication Systems, Ltd., this product is identified by NDC 76329-3669 and is authorized under FDA application NDA208969.

Identification & Billing

NDC Package Code
76329-3669-2
Package Description
2 CONTAINER in 1 CONTAINER / .25 mL in 1 CONTAINER
Product Code
76329-3669
11-Digit Billing Format
76329366902
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
Rextovy
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/.25mL
Pharmacologic Class
Usage Information
Naloxone Hydrochloride Nasal Spray is indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.Naloxone Hydrochloride Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.Naloxone Hydrochloride Nasal Spray is not a substitute for emergency medical care.

Regulatory & Marketing

Labeler Name
International Medication Systems, Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA208969
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-07-2024
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 76329-3669-2 identifies a specific commercial package of 2 container in 1 container / .25 ml in 1 container of Rextovy, a human prescription drug labeled by International Medication Systems, Ltd.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 International Medication Systems, Ltd. on May 07, 2024. The current certification is valid through December 31, 2026.

How is this International Medication Systems, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76329366902. 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 (5-4-1)
76329-3669-2
11-Digit CMS (5-4-2)
76329-3669-02

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