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  5. NDC Package Code: 70518-4208-0 Procainamide Hydrochloride

NDC Package 70518-4208-0 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:
70518-4208-0
Package Description:
5 SYRINGE in 1 PACKAGE / 10 mL in 1 SYRINGE (70518-4208-1)
Product Code:
70518-4208
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 WARNINGSand Boxed Warning.)
11-Digit NDC Billing Format:
70518420800
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:
Remedyrepack Inc.
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:
10-10-2024
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 70518-4208-0?

The NDC Packaged Code 70518-4208-0 is assigned to a package of 5 syringe in 1 package / 10 ml in 1 syringe (70518-4208-1) of Procainamide Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is injection and is administered via intramuscular; intravenous form.

Is NDC 70518-4208 included in the NDC Directory?

Yes, Procainamide Hydrochloride with product code 70518-4208 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on October 10, 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 70518-4208-0?

The 11-digit format is 70518420800. 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
5-4-170518-4208-05-4-270518-4208-00