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  5. NDC Package Code: 82432-101-01 Nalmefene Hydrochloride

NDC Package 82432-101-01 Nalmefene Hydrochloride

Nalmefene Hydrochloride Injection Solution Intramuscular; Intravenous; Subcutaneous - 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:
82432-101-01
Package Description:
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS
Product Code:
82432-101
Proprietary Name:
Nalmefene Hydrochloride
Non-Proprietary Name:
Nalmefene Hydrochloride Injection
Substance Name:
Nalmefene Hydrochloride
Usage Information:
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.
11-Digit NDC Billing Format:
82432010101
NDC to RxNorm Crosswalk:
  • RxCUI: 2592953 - nalmefene hydrochloride 2 MG in 2 ML Injection
  • RxCUI: 2592953 - 2 ML nalmefene 1 MG/ML Injection
  • RxCUI: 2592953 - nalmefene (as nalmefene hydrochloride) 2 MG per 2 ML Injection
  • RxCUI: 2672926 - nalmefene 100 MCG in 1 ML Injection
  • RxCUI: 2672926 - 1 ML nalmefene 0.1 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Chengdu Shuode Pharmaceutical Co., Ltd
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • NALMEFENE HYDROCHLORIDE .1 mg/mL
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216007
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-15-2023
    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 82432-101-01?

    The NDC Packaged Code 82432-101-01 is assigned to a package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass of Nalmefene Hydrochloride, a human prescription drug labeled by Chengdu Shuode Pharmaceutical Co., Ltd. The product's dosage form is solution and is administered via intramuscular; intravenous; subcutaneous form.

    Is NDC 82432-101 included in the NDC Directory?

    Yes, Nalmefene Hydrochloride with product code 82432-101 is active and included in the NDC Directory. The product was first marketed by Chengdu Shuode Pharmaceutical Co., Ltd on November 15, 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 11-digit format for NDC 82432-101-01?

    The 11-digit format is 82432010101. 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
    5-3-282432-101-015-4-282432-0101-01