Quinidine Gluconate
NDC Package 54738-901-02

11-digit billing NDC: 54738090102 · Billing unit: EA · 500 EA per package
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 discontinued by the firm.

Quinidine Gluconate is quinidine is contraindicated in patients who are known to be allergic to it, or who have a history of immune thrombocytopenia or have developed thrombocytopenic purpura during prior therapy with quinidine or quinine (see WARNINGS).In the absence of a functioning artificial pacemaker, quinidine is also contraindicated in any patient whose cardiac rhythm is dependent upon a junctional or idioventricular pacemaker, including patients in complete atrioventricular block.Quinidine is also contraindicated in patients who, like those with myasthenia gravis, might be adversely affected by an anticholinergic agent. Marketed by Richmond Pharmaceuticals, Inc., this product is identified by NDC 54738-901 and is authorized under FDA application ANDA089338.

Identification & Billing

NDC Package Code
54738-901-02
Package Description
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
54738-901
11-Digit Billing Format
54738090102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA

Clinical Specifications

Proprietary Name
Quinidine Gluconate
Dosage Form
-
Usage Information
Quinidine is contraindicated in patients who are known to be allergic to it, or who have a history of immune thrombocytopenia or have developed thrombocytopenic purpura during prior therapy with quinidine or quinine (see WARNINGS).In the absence of a functioning artificial pacemaker, quinidine is also contraindicated in any patient whose cardiac rhythm is dependent upon a junctional or idioventricular pacemaker, including patients in complete atrioventricular block.Quinidine is also contraindicated in patients who, like those with myasthenia gravis, might be adversely affected by an anticholinergic agent.

Regulatory & Marketing

Labeler Name
Richmond Pharmaceuticals, Inc.
FDA Application #
ANDA089338
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-10-1987
End Marketing Date
07-31-2023
Listing Expiration
07-31-2023
Exclude Flag
D
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 (54738-901). Click a package code to view its specific billing and regulatory data.

54738-901-01
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 54738-901-02 identifies a specific commercial package of 500 tablet, extended release in 1 bottle, plastic of Quinidine Gluconate, labeled by Richmond Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. 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 Richmond Pharmaceuticals, Inc. on February 10, 1987. The current certification is valid through July 31, 2023.

How is this Richmond Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54738090102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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)
54738-901-02
11-Digit CMS (5-4-2)
54738-0901-02

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