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  5. NDC Package Code: 55150-427-10 Diltiazem Hydrochloride

NDC Package 55150-427-10 Diltiazem Hydrochloride

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:
55150-427-10
Package Description:
10 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE (55150-427-01)
Product Code:
55150-427
Proprietary Name:
Diltiazem Hydrochloride
Non-Proprietary Name:
Diltiazem Hydrochloride
Substance Name:
Diltiazem Hydrochloride
Usage Information:
Diltiazem hydrochloride injection is indicated for the following:Atrial Fibrillation or Atrial FlutterTemporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome.Paroxysmal Supraventricular TachycardiaRapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection.The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours.A 24 hour continuous infusion of diltiazem hydrochloride injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent.In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.
11-Digit NDC Billing Format:
55150042710
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1791229 - dilTIAZem hydrochloride 25 MG in 5 mL Injection
  • RxCUI: 1791229 - 5 ML diltiazem hydrochloride 5 MG/ML Injection
  • RxCUI: 1791229 - diltiazem hydrochloride 25 MG per 5 ML Injection
  • RxCUI: 1791232 - dilTIAZem hydrochloride 50 MG in 10 mL Injection
  • RxCUI: 1791232 - 10 ML diltiazem hydrochloride 5 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Eugia Us Llc
    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):
  • DILTIAZEM HYDROCHLORIDE 5 mg/mL
    • Pharmacologic Class(es):
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA216552
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-29-2023
    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 55150-427-10?

    The NDC Packaged Code 55150-427-10 is assigned to a package of 10 vial, single-dose in 1 carton / 25 ml in 1 vial, single-dose (55150-427-01) of Diltiazem Hydrochloride, a human prescription drug labeled by Eugia Us Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 55150-427 included in the NDC Directory?

    Yes, Diltiazem Hydrochloride with product code 55150-427 is active and included in the NDC Directory. The product was first marketed by Eugia Us Llc on March 29, 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 NDC billing unit for package 55150-427-10?

    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 55150-427-10?

    The 11-digit format is 55150042710. 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
    5-3-255150-427-105-4-255150-0427-10