Quinine Sulfate
NDC Package 52682-501-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Quinine Sulfate is a medication used alone or with other medication to treat malaria caused by mosquito bites in countries where malaria is common. Marketed by Ingenus Pharmaceuticals Nj, Llc, this product is identified by NDC 52682-501 and is authorized under FDA application ANDA204372.

Identification & Billing

NDC Package Code
52682-501-01
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
52682-501
11-Digit Billing Format
52682050101

Clinical Specifications

Proprietary Name
Quinine Sulfate
Dosage Form
-
Usage Information
This medication is used alone or with other medication to treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in other body tissues. Both drugs may be needed for a complete cure and to prevent the return of infection (relapse). Quinine belongs to a class of drugs known as antimalarials. It is not used for the prevention of malaria. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

Regulatory & Marketing

Labeler Name
Ingenus Pharmaceuticals Nj, Llc
FDA Application #
ANDA204372
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-23-2015
End Marketing Date
12-07-2017
Listing Expiration
12-07-2017
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 (52682-501). Click a package code to view its specific billing and regulatory data.

52682-501-03
500 CAPSULE in 1 BOTTLE, PLASTIC
52682-501-09
30 CAPSULE 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 52682-501-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Quinine Sulfate, labeled by Ingenus Pharmaceuticals Nj, Llc. 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 Ingenus Pharmaceuticals Nj, Llc on July 23, 2015. The current certification is valid through December 07, 2017.

What are the primary indications for this medication?

This medication is used alone or with other medication to treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in other body tissues. Both drugs may be needed for a complete cure and to prevent the return of infection (relapse). Quinine belongs to a class of drugs known as antimalarials. It is not used for the prevention of malaria. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

How is this Ingenus Pharmaceuticals Nj, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52682050101. 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)
52682-501-01
11-Digit CMS (5-4-2)
52682-0501-01

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