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  5. NDC Package Code: 50090-6963-0 Naloxone Hydrochloride

NDC Package 50090-6963-0 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:
50090-6963-0
Package Description:
2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
50090-6963
Proprietary Name:
Naloxone Hydrochloride
Non-Proprietary Name:
Naloxone Hydrochloride
Substance Name:
Naloxone Hydrochloride
Usage Information:
Step 1: CHECK if you suspect an overdose:• CHECK for a suspected overdose: the person will not wake up or is very sleepy or not breathing well• yell “Wake up!”• shake the person gently• if the person is not awake, go to Step 2Step 2: GIVE 1st dose in the nose• HOLD the nasal spray device with your thumb on the bottom of the plunger• INSERT the nozzle into either NOSTRIL• PRESS the plunger firmly to give the 1st dose• 1 nasal spray device contains 1 doseStep 3: CALL• CALL 911immediately after giving the 1st doseStep 4: WATCH & GIVE• WAIT2-3 minutes after the 1st dose to give the medicine time to work• if the person wakes up: Go to Step 5• if the person does not wake up:   • CONTINUE TO GIVE doses every 2-3 minutes until the person wakes up• it is safe to keep giving dosesStep 5: STAY• STAY until ambulance arrives: even if the person wakes up• GIVE another dose if the person becomes very sleepy again• You may need to give all the doses in the pack
11-Digit NDC Billing Format:
50090696300
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: 1725059 - naloxone HCl 4 MG per 0.1 ML Nasal Spray
  • RxCUI: 1725059 - naloxone hydrochloride 40 MG/ML Nasal Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    A-s Medication Solutions
    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/.1mL
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA211951
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-30-2023
    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 50090-6963-0?

    The NDC Packaged Code 50090-6963-0 is assigned to a package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, a human over the counter drug labeled by A-s Medication Solutions. 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 50090-6963 included in the NDC Directory?

    Yes, Naloxone Hydrochloride with product code 50090-6963 is active and included in the NDC Directory. The product was first marketed by A-s Medication Solutions on July 30, 2023 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 50090-6963-0?

    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 50090-6963-0?

    The 11-digit format is 50090696300. 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
    5-4-150090-6963-05-4-250090-6963-00