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  5. NDC Package Code: 65841-840-06 Amiodarone Hydrochloride

NDC Package 65841-840-06 Amiodarone Hydrochloride

Tablet Oral - 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:
65841-840-06
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
65841-840
Proprietary Name:
Amiodarone Hydrochloride
Non-Proprietary Name:
Amiodarone Hydrochloride
Substance Name:
Amiodarone Hydrochloride
Usage Information:
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), amiodarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.Recurrent ventricular fibrillation.Recurrent hemodynamically unstable ventricular tachycardia.As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival.Amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital.
11-Digit NDC Billing Format:
65841084006
NDC to RxNorm Crosswalk:
  • RxCUI: 833528 - amiodarone HCl 200 MG Oral Tablet
  • RxCUI: 833528 - amiodarone hydrochloride 200 MG Oral Tablet
  • RxCUI: 834348 - amiodarone HCl 400 MG Oral Tablet
  • RxCUI: 834348 - amiodarone hydrochloride 400 MG Oral Tablet
  • RxCUI: 835956 - amiodarone HCl 100 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMIODARONE HYDROCHLORIDE 100 mg/1
    • Pharmacologic Class(es):
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA079029
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-09-2023
    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 65841-840-06?

    The NDC Packaged Code 65841-840-06 is assigned to a package of 30 tablet in 1 bottle of Amiodarone Hydrochloride, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65841-840 included in the NDC Directory?

    Yes, Amiodarone Hydrochloride with product code 65841-840 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on February 09, 2023 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 11-digit format for NDC 65841-840-06?

    The 11-digit format is 65841084006. 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
    5-3-265841-840-065-4-265841-0840-06