Verapamil Hydrochloride
NDC Package 59923-606-04

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

Package Information

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

Verapamil Hydrochloride is intravenous verapamil hydrochloride injection is indicated for the following:Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). Marketed by Areva Pharmaceuticals, this product is identified by NDC 59923-606 and is authorized under FDA application ANDA213352.

Identification & Billing

NDC Package Code
59923-606-04
Package Description
5 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code
59923-606
11-Digit Billing Format
59923060604
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Verapamil Hydrochloride
Dosage Form
-
Usage Information
Intravenous verapamil hydrochloride injection is indicated for the following:Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride injection administration.Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride injection. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a fast ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride injection and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.Because a small fraction (<1%) of patients treated with verapamil hydrochloride injection respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole – see CONTRAINDICATIONS and WARNINGS), the initial use of intravenous verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including DC-cardioversion capability (see ADVERSE REACTIONS:Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable . Cardioversion has been used safely and effectively after verapamil hydrochloride injection.

Regulatory & Marketing

Labeler Name
Areva Pharmaceuticals
FDA Application #
ANDA213352
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2025
Listing Expiration
12-31-2022
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59923-606-04 identifies a specific commercial package of 5 vial in 1 carton / 4 ml in 1 vial of Verapamil Hydrochloride, labeled by Areva Pharmaceuticals. 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 Areva Pharmaceuticals on January 01, 2025. The current certification is valid through December 31, 2022.

How is this Areva Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59923060604. 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)
59923-606-04
11-Digit CMS (5-4-2)
59923-0606-04

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