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  5. NDC Package Code: 53489-700-01 Quinine Sulfate

NDC Package 53489-700-01 Quinine Sulfate

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53489-700-01
Package Description:
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
53489-700
Proprietary Name:
Quinine Sulfate
Non-Proprietary Name:
Quinine Sulfate
Substance Name:
Quinine Sulfate
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.
11-Digit NDC Billing Format:
53489070001
NDC to RxNorm Crosswalk:
  • RxCUI: 997010 - quiNINE sulfate 324 MG Oral Capsule
  • RxCUI: 997010 - quinine sulfate 324 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • QUININE SULFATE 324 mg/1
    • Pharmacologic Class(es):
  • Antimalarial - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA021799
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    07-23-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53489-700-0730 CAPSULE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53489-700-01?

    The NDC Packaged Code 53489-700-01 is assigned to a package of 100 capsule in 1 bottle, plastic of Quinine Sulfate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 53489-700 included in the NDC Directory?

    Yes, Quinine Sulfate with product code 53489-700 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on July 23, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53489-700-01?

    The 11-digit format is 53489070001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253489-700-015-4-253489-0700-01