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  5. NDC Package Code: 51754-3500-3 Diltiazem Hydrochloride

NDC Package 51754-3500-3 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:
51754-3500-3
Package Description:
10 BAG in 1 CARTON / 250 mL in 1 BAG
Product Code:
51754-3500
Proprietary Name:
Diltiazem Hydrochloride
Non-Proprietary Name:
Diltiazem Hydrochloride
Substance Name:
Diltiazem Hydrochloride
Usage Information:
Diltiazem Hydrochloride Injection is contraindicated in: •Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. •Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. •Patients with severe hypotension or cardiogenic shock. •Patients who have demonstrated hypersensitivity to the drug. •Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). •Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome.As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present [see Overdosage (10)]. Once familiarity of the patient's response is established, use in an office setting may be acceptable. •Patients with ventricular tachycardia. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS ≥ 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. It is important that an accurate pretreatment diagnosis distinguish wide complex QRS tachycardia of supraventricular origin from that of ventricular origin prior to administration of diltiazem hydrochloride injection.
11-Digit NDC Billing Format:
51754350003
NDC to RxNorm Crosswalk:
  • RxCUI: 2586034 - dilTIAZem hydrochloride 125 MG in 125 ML Injection
  • RxCUI: 2586034 - 125 ML diltiazem hydrochloride 1 MG/ML Injection
  • RxCUI: 2586034 - diltiazem hydrochloride 125 MG per 125 ML Injection
  • RxCUI: 2586036 - dilTIAZem hydrochloride 250 MG in 250 ML Injection
  • RxCUI: 2586036 - 250 ML diltiazem hydrochloride 1 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Exela Pharma Sciences,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 1 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:
    NDA215252
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-30-2021
    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 51754-3500-3?

    The NDC Packaged Code 51754-3500-3 is assigned to a package of 10 bag in 1 carton / 250 ml in 1 bag of Diltiazem Hydrochloride, a human prescription drug labeled by Exela Pharma Sciences,llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 51754-3500 included in the NDC Directory?

    Yes, Diltiazem Hydrochloride with product code 51754-3500 is active and included in the NDC Directory. The product was first marketed by Exela Pharma Sciences,llc on November 30, 2021 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 51754-3500-3?

    The 11-digit format is 51754350003. 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 5-4-1 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
    5-4-151754-3500-35-4-251754-3500-03