Quinidine Sulfate Tablet
NDC Package 42806-513-01

11-digit billing NDC: 42806051301
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Quinidine Sulfate (quinidine sulfate tablet) tablets is quinidine is contraindicated in patients who are known to be allergic to it, or who have developed thrombocytopenic purpura during prior therapy with quinidine or quinine.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. This formulation utilizes a tablet delivery system. Marketed by Epic Pharma, Llc, this product is identified by NDC 42806-513 and is authorized under FDA application ANDA088072.

Identification & Billing

NDC Package Code
42806-513-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
42806-513
11-Digit Billing Format
42806051301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quinidine Sulfate
Non-Proprietary Name
Quinidine Sulfate Tablet
Substance Name
Quinidine Sulfate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
QUINIDINE SULFATE 200 mg/1
Pharmacologic Class
Usage Information
Quinidine is contraindicated in patients who are known to be allergic to it, or who have developed thrombocytopenic purpura during prior therapy with quinidine or quinine.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
Epic Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA088072
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2021
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 (42806-513). Click a package code to view its specific billing and regulatory data.

42806-513-30
30 TABLET in 1 BOTTLE

* 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 42806-513-01 identifies a specific commercial package of 100 tablet in 1 bottle of Quinidine Sulfate, a human prescription drug labeled by Epic Pharma, Llc. This tablet is formulated for oral use and contains quinidine sulfate 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 Epic Pharma, Llc on December 15, 2021. The current certification is valid through December 31, 2026.

How is this Epic Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42806051301. 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)
42806-513-01
11-Digit CMS (5-4-2)
42806-0513-01

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