Quinidine Gluconate Powder
NDC Package 12065-1702-3

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Quinidine Gluconate powders is a medication used to treat or prevent many types of irregular heartbeats (heart arrhythmias such as atrial fibrillation). This formulation utilizes a powder delivery system. Marketed by Buchler Gmbh, this product is identified by NDC 12065-1702.

Identification & Billing

NDC Package Code
12065-1702-3
Package Description
25 kg in 1 PACKAGE
Product Code
12065-1702
11-Digit Billing Format
12065170203

Clinical Specifications

Proprietary Name
Quinidine Gluconate
Non-Proprietary Name
Quinidine Gluconate
Substance Name
Quinidine Gluconate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
QUINIDINE GLUCONATE 1 kg/kg
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
Buchler Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-20-1983
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (12065-1702). Click a package code to view its specific billing and regulatory data.

12065-1702-1
5 kg in 1 PACKAGE
12065-1702-2
50 kg in 1 PACKAGE

* 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 12065-1702-3 identifies a specific commercial package of 25 kg in 1 package of Quinidine Gluconate (UNFINISHED drug), a bulk ingredient labeled by Buchler Gmbh. This powder is formulated for 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 Buchler Gmbh on January 20, 1983. 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 Buchler Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12065170203. 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)
12065-1702-3
11-Digit CMS (5-4-2)
12065-1702-03

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