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  5. NDC Package Code: 76329-3669-2 Rextovy

NDC Package 76329-3669-2 Rextovy

Naloxone Hydrochloride Spray Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
76329-3669-2
Package Description:
2 CONTAINER in 1 CONTAINER / .25 mL in 1 CONTAINER
Product Code:
76329-3669
Proprietary Name:
Rextovy
Non-Proprietary Name:
Naloxone Hydrochloride
Substance Name:
Naloxone Hydrochloride
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.
11-Digit NDC Billing Format:
76329366902
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2637879 - naloxone hydrochloride 4 MG in 0.25 mL Nasal Spray
  • RxCUI: 2637879 - naloxone hydrochloride 16 MG/ML Nasal Spray
  • RxCUI: 2637879 - naloxone hydrochloride (naloxone 3.6 MG) 4 MG per 0.25 ML Nasal Spray
  • RxCUI: 2680741 - REXTOVY 4 MG in 0.25 ML Nasal Spray
  • RxCUI: 2680741 - naloxone hydrochloride 16 MG/ML Nasal Spray [Rextovy]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    International Medication Systems, Ltd.
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • NALOXONE HYDROCHLORIDE 4 mg/.25mL
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA208969
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-07-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 76329-3669-2?

    The NDC Packaged Code 76329-3669-2 is assigned to a package of 2 container in 1 container / .25 ml in 1 container of Rextovy, a human prescription drug labeled by International Medication Systems, Ltd.. The product's dosage form is spray and is administered via nasal form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 76329-3669 included in the NDC Directory?

    Yes, Rextovy with product code 76329-3669 is active and included in the NDC Directory. The product was first marketed by International Medication Systems, Ltd. on May 07, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 76329-3669-2?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 76329-3669-2?

    The 11-digit format is 76329366902. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-176329-3669-25-4-276329-3669-02