Quinidine Gluconate Tablet, Extended Release
NDC Package 53489-141-07

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

Quinidine Gluconate tablets is a medication used to treat or prevent many types of irregular heartbeats (heart arrhythmias such as atrial fibrillation). This formulation utilizes a tablet, extended release delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 53489-141 and is authorized under FDA application ANDA089338.

Identification & Billing

NDC Package Code
53489-141-07
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
53489-141
11-Digit Billing Format
53489014107
RxNorm Crosswalk
  • RxCUI: 852920 - quiNIDine gluconate 324 MG Extended Release Oral Tablet
  • RxCUI: 852920 - quinidine gluconate 324 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Quinidine Gluconate
Non-Proprietary Name
Quinidine Gluconate
Substance Name
Quinidine Gluconate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
QUINIDINE GLUCONATE 324 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat or prevent many types of irregular heartbeats (heart arrhythmias such as atrial fibrillation). Quinidine can greatly improve your ability to perform normal activities by decreasing the number of irregular heartbeats you have. However, it may not stop all your irregular heartbeats completely. It works by blocking abnormal heartbeat signals. Before and while you are using quinidine, your doctor may prescribe other medications (e.g., "blood thinners"/anticoagulants such as warfarin, beta blockers such as metoprolol) to shrink any blood clots in the heart and to slow your pulse.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA089338
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-10-1987
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53489-141). Click a package code to view its specific billing and regulatory data.

53489-141-01
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
53489-141-03
250 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
53489-141-05
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
53489-141-06
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
53489-141-10
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
53489-141-90
90 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 53489-141-07 identifies a specific commercial package of 30 tablet, extended release in 1 bottle, plastic of Quinidine Gluconate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, extended release is formulated for oral use and contains quinidine gluconate 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 Sun Pharmaceutical Industries, Inc. on February 10, 1987. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat or prevent many types of irregular heartbeats (heart arrhythmias such as atrial fibrillation). Quinidine can greatly improve your ability to perform normal activities by decreasing the number of irregular heartbeats you have. However, it may not stop all your irregular heartbeats completely. It works by blocking abnormal heartbeat signals. Before and while you are using quinidine, your doctor may prescribe other medications (e.g., "blood thinners"/anticoagulants such as warfarin, beta blockers such as metoprolol) to shrink any blood clots in the heart and to slow your pulse.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53489014107. 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)
53489-141-07
11-Digit CMS (5-4-2)
53489-0141-07

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