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  5. NDC Package Code: 76329-3399-5 Procainamide Hydrochloride

NDC Package 76329-3399-5 Procainamide Hydrochloride

Injection Intramuscular; 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:
76329-3399-5
Package Description:
5 SYRINGE in 1 PACKAGE / 10 mL in 1 SYRINGE
Product Code:
76329-3399
Proprietary Name:
Procainamide Hydrochloride
Non-Proprietary Name:
Procainamide Hydrochloride
Substance Name:
Procainamide Hydrochloride
Usage Information:
Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGS and Boxed Warning.)
11-Digit NDC Billing Format:
76329339905
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1862220 - procainamide HCl 1000 MG in 10 ML Prefilled Syringe
  • RxCUI: 1862220 - 10 ML procainamide hydrochloride 100 MG/ML Prefilled Syringe
  • RxCUI: 1862220 - procainamide HCl 1000 MG per 10 ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    International Medication Systems, Limited
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PROCAINAMIDE HYDROCHLORIDE 100 mg/mL
    • Pharmacologic Class(es):
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA088636
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-21-2016
    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 76329-3399-5?

    The NDC Packaged Code 76329-3399-5 is assigned to a package of 5 syringe in 1 package / 10 ml in 1 syringe of Procainamide Hydrochloride, a human prescription drug labeled by International Medication Systems, Limited. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 76329-3399 included in the NDC Directory?

    Yes, Procainamide Hydrochloride with product code 76329-3399 is active and included in the NDC Directory. The product was first marketed by International Medication Systems, Limited on December 21, 2016 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 76329-3399-5?

    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 76329-3399-5?

    The 11-digit format is 76329339905. 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
    5-4-176329-3399-55-4-276329-3399-05