Quinidine Gluconate
NDC Package 51079-027-20

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 discontinued by the firm.

Quinidine Gluconate is a medication used to treat or prevent many types of irregular heartbeats (heart arrhythmias such as atrial fibrillation). Marketed by Udl Laboratories, Inc., this product is identified by NDC 51079-027 and is authorized under FDA application ANDA089338.

Identification & Billing

NDC Package Code
51079-027-20
Package Description
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01)
Product Code
51079-027
11-Digit Billing Format
51079002720
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Quinidine Gluconate
Dosage Form
-
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
Udl Laboratories, Inc.
FDA Application #
ANDA089338
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2000
End Marketing Date
10-31-2014
Listing Expiration
10-31-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51079-027-20 identifies a specific commercial package of 100 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack (51079-027-01) of Quinidine Gluconate, labeled by Udl Laboratories, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 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 Udl Laboratories, Inc. on May 01, 2000. The current certification is valid through October 31, 2014.

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 Udl Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51079002720. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
51079-027-20
11-Digit CMS (5-4-2)
51079-0027-20

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