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  5. NDC Package Code: 23155-326-31 Ibutilide Fumarate

NDC Package 23155-326-31 Ibutilide Fumarate

Injection, Solution Intravenous - 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:
23155-326-31
Package Description:
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code:
23155-326
Proprietary Name:
Ibutilide Fumarate
Non-Proprietary Name:
Ibutilide Fumarate
Substance Name:
Ibutilide Fumarate
Usage Information:
Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of Ibutilide fumarate. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia). It is essential that Ibutilide fumarate be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. Patients with atrial fibrillation of more than 2 to 3 days’ duration must be adequately anticoagulated, generally for at least 2 weeks. CHOICE OF PATIENTS Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see CLINICAL STUDIES) and treatments to maintain sinus rhythm carry risks. Patients to be treated with Ibutilide fumarate , therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of Ibutilide fumarate , and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.
11-Digit NDC Billing Format:
23155032631
NDC to RxNorm Crosswalk:
  • RxCUI: 979120 - ibutilide fumarate 1 MG in 10 ML Injection
  • RxCUI: 979120 - 10 ML ibutilide fumarate 0.1 MG/ML Injection
  • RxCUI: 979120 - ibutilide fumarate 1 MG (equivalent to ibutilide 0.087 MG) per 10 ML Injection
  • RxCUI: 979120 - ibutilide fumarate 1 MG per 10 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals 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):
  • IBUTILIDE FUMARATE 1 mg/10mL
    • Pharmacologic Class(es):
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204146
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2024
    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 23155-326-31?

    The NDC Packaged Code 23155-326-31 is assigned to a package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Ibutilide Fumarate, a human prescription drug labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 23155-326 included in the NDC Directory?

    Yes, Ibutilide Fumarate with product code 23155-326 is active and included in the NDC Directory. The product was first marketed by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. on April 01, 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 11-digit format for NDC 23155-326-31?

    The 11-digit format is 23155032631. 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
    5-3-223155-326-315-4-223155-0326-31