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  5. NDC Package Code: 0093-2165-68 Naloxone Hydrochloride

NDC Package 0093-2165-68 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:
0093-2165-68
Package Description:
2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0093-2165-19) / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0093-2165
Proprietary Name:
Naloxone Hydrochloride
Non-Proprietary Name:
Naloxone Hydrochloride
Substance Name:
Naloxone Hydrochloride
Usage Information:
Naloxone hydrochloride 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 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.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:
00093216568
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 Prescription Drug
    Labeler Name:
    Teva Pharmaceuticals Usa, 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):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209522
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-22-2021
    Listing Expiration Date:
    12-31-2024
    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 0093-2165-68?

    The NDC Packaged Code 0093-2165-68 is assigned to a package of 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack (0093-2165-19) / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is spray, metered and is administered via nasal form.

    Is NDC 0093-2165 included in the NDC Directory?

    Yes, Naloxone Hydrochloride with product code 0093-2165 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on December 22, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0093-2165-68?

    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 0093-2165-68?

    The 11-digit format is 00093216568. 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
    4-4-20093-2165-685-4-200093-2165-68