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

NDC Package 45802-811-84 Naloxone Hydrochloride

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

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
Non-Proprietary Name:
Naloxone Hydrochloride
Substance 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
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Padagis Israel Pharmaceuticals 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/.1mL
Pharmacologic Class(es):
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
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 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, a human prescription drug labeled by Padagis Israel Pharmaceuticals 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 45802-811 included in the NDC Directory?

Yes, Naloxone Hydrochloride with product code 45802-811 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on June 21, 2022.

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