Procainamide Hydrochloride Injection
NDC Package 76329-3399-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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 delivery system. Marketed by International Medication Systems, Limited, this product is identified by NDC 76329-3399 and is authorized under FDA application ANDA088636.

Identification & Billing

NDC Package Code
76329-3399-5
Package Description
5 SYRINGE in 1 PACKAGE / 10 mL in 1 SYRINGE
Product Code
76329-3399
11-Digit Billing Format
76329339905
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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

Clinical Specifications

Proprietary Name
Procainamide Hydrochloride
Non-Proprietary Name
Procainamide Hydrochloride
Substance Name
Procainamide Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PROCAINAMIDE HYDROCHLORIDE 100 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
International Medication Systems, Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA088636
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-21-2016
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2690
Source: PDAC
INJECTION, PROCAINAMIDE HCL, UP TO 1 GM
HCPCS Dosage 1 GM
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 76329-3399-5 identifies a specific commercial 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. This injection 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 International Medication Systems, Limited on December 21, 2016. The current certification is valid through December 31, 2026.

How is this International Medication Systems, Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76329339905. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
76329-3399-5
11-Digit CMS (5-4-2)
76329-3399-05

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