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  5. NDC Package Code: 0480-3478-68 Naloxone Hydrochloride

NDC Package 0480-3478-68 Naloxone Hydrochloride

Spray, Metered 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:
0480-3478-68
Package Description:
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0480-3478
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 wellyell “Wake up!”shake the person gently if the person is not awake, go to Step 2 Step 2: GIVE 1st dose in the noseHOLD the nasal spray device with your thumb on the bottom of the plungerINSERT the nozzle into either NOSTRILPRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose  Step 3: CALL CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1st dose to give the medicine time to work if the person wakes up: Go to Step 5if 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 doses Step 5: STAYSTAY until ambulance arrives: even if the person wakes upGIVE 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:
00480347868
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 Otc Drug
Labeler Name:
Teva Pharmaceuticals, Inc.
Dosage Form:
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
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:
ANDA209522
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-23-2024
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 0480-3478-68?

The NDC Packaged Code 0480-3478-68 is assigned to a package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack (0480-3478-19) / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, a human over the counter drug labeled by Teva Pharmaceuticals, Inc.. The product's dosage form is spray, metered and is administered via nasal form.

Is NDC 0480-3478 included in the NDC Directory?

Yes, Naloxone Hydrochloride with product code 0480-3478 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals, Inc. on September 23, 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 0480-3478-68?

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 0480-3478-68?

The 11-digit format is 00480347868. 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 4-4-2 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
4-4-20480-3478-685-4-200480-3478-68