Procainamide Hydrochloride Injection, Solution
NDC Package 68083-604-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-604 and is authorized under FDA application ANDA218135.

Identification & Billing

NDC Package Code
68083-604-25
Package Description
25 VIAL, MULTI-DOSE in 1 CASE / 2 mL in 1 VIAL, MULTI-DOSE
Product Code
68083-604
11-Digit Billing Format
68083060425
RxNorm Crosswalk
  • RxCUI: 857886 - procainamide HCl 100 MG/ML Injectable Solution
  • RxCUI: 857886 - procainamide hydrochloride 100 MG/ML Injectable Solution
  • RxCUI: 857962 - procainamide HCl 500 MG/ML Injectable Solution
  • RxCUI: 857962 - procainamide hydrochloride 500 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Procainamide Hydrochloride
Non-Proprietary Name
Procainamide Hydrochloride
Substance Name
Procainamide Hydrochloride
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PROCAINAMIDE HYDROCHLORIDE 500 mg/mL
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
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.)

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68083-604-25 identifies a specific commercial package of 25 vial, multi-dose in 1 case / 2 ml in 1 vial, multi-dose of Procainamide Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intramuscular; intravenous use and contains procainamide hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Gland Pharma Limited on July 22, 2024. The current certification is valid through December 31, 2026.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083060425. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68083-604-25
11-Digit CMS (5-4-2)
68083-0604-25

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.