Procainamide Hci
NDC Package 51662-1392-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Procainamide Hci is 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. Marketed by Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1392 and is authorized under FDA application ANDA089070.

Identification & Billing

NDC Package Code
51662-1392-3
Package Description
25 POUCH in 1 CASE / 1 mL in 1 POUCH (51662-1392-2)
Product Code
51662-1392
11-Digit Billing Format
51662139203
RxNorm Crosswalk
  • RxCUI: 857962 - procainamide HCl 500 MG/ML Injectable Solution
  • RxCUI: 857962 - procainamide hydrochloride 500 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Procainamide Hci
Dosage Form
-
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
Hf Acquisition Co Llc, Dba Healthfirst
FDA Application #
ANDA089070
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-2019
Listing Expiration
12-31-2025
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51662-1392). Click a package code to view its specific billing and regulatory data.

51662-1392-1
2 mL in 1 VIAL, MULTI-DOSE

* 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 51662-1392-3 identifies a specific commercial package of 25 pouch in 1 case / 1 ml in 1 pouch (51662-1392-2) of Procainamide Hci, labeled by Hf Acquisition Co Llc, Dba Healthfirst. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hf Acquisition Co Llc, Dba Healthfirst on October 16, 2019. The current certification is valid through December 31, 2025.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662139203. 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)
51662-1392-3
11-Digit CMS (5-4-2)
51662-1392-03

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