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  5. NDC Package Code: 0143-9875-10 Amiodarone Hydrochloride

NDC Package 0143-9875-10 Amiodarone Hydrochloride

Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0143-9875-10
Package Description:
10 VIAL in 1 BOX / 3 mL in 1 VIAL (0143-9875-01)
Product Code:
0143-9875
Proprietary Name:
Amiodarone Hydrochloride
Non-Proprietary Name:
Amiodarone Hydrochloride
Substance Name:
Amiodarone Hydrochloride
Usage Information:
Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)].Use Amiodarone Hydrochloride Injection for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection may be safely administered for longer periods if necessary.
11-Digit NDC Billing Format:
00143987510
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1663224 - amiodarone HCl 150 MG in 3 ML Injection
  • RxCUI: 1663224 - 3 ML amiodarone hydrochloride 50 MG/ML Injection
  • RxCUI: 1663224 - amiodarone HCl 150 MG per 3 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • AMIODARONE HYDROCHLORIDE 50 mg/mL
    • 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 3A Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077234
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-25-2008
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0143-9875-2525 VIAL in 1 BOX / 3 mL in 1 VIAL (0143-9875-01)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0143-9875-10?

    The NDC Packaged Code 0143-9875-10 is assigned to a package of 10 vial in 1 box / 3 ml in 1 vial (0143-9875-01) of Amiodarone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0143-9875 included in the NDC Directory?

    Yes, Amiodarone Hydrochloride with product code 0143-9875 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on February 25, 2008 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 0143-9875-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0143-9875-10?

    The 11-digit format is 00143987510. 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
    4-4-20143-9875-105-4-200143-9875-10