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  5. NDC Package Code: 45802-811-84 Naloxone Hydrochloride

NDC Package 45802-811-84 Naloxone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
45802-811-84
Package Description:
2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE (45802-811-00)
Product Code:
45802-811
Proprietary Name:
Naloxone Hydrochloride
Usage Information:
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.Naloxone HCl Nasal Spray is not a substitute for emergency medical care.Limitations of Use:Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
11-Digit NDC Billing Format:
45802081184
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
Labeler Name:
Padagis Israel Pharmaceuticals Ltd
Sample Package:
No
FDA Application Number:
ANDA211951
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-21-2022
End Marketing Date:
09-30-2025
Listing Expiration Date:
09-30-2025
Exclude Flag:
D
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 45802-811-84?

The NDC Packaged Code 45802-811-84 is assigned to a package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose (45802-811-00) of Naloxone Hydrochloride, labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 45802-811 included in the NDC Directory?

No, Naloxone Hydrochloride with product code 45802-811 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on June 21, 2022 and its listing in the NDC Directory is set to expire on September 30, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 45802-811-84?

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 45802-811-84?

The 11-digit format is 45802081184. 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 5-3-2 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
5-3-245802-811-845-4-245802-0811-84