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  5. NDC Package Code: 65841-103-12 Hydroxychloroquine Sulfate

NDC Package 65841-103-12 Hydroxychloroquine Sulfate

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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.

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:
65841-103-12
Package Description:
1 BAG in 1 DRUM / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 35 kg in 1 BAG
Product Code:
65841-103
Non-Proprietary Name:
Hydroxychloroquine Sulfate
Substance Name:
Hydroxychloroquine Sulfate
Usage Information:
Hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. The United States Center for Disease Control provides 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. This medication is also used to treat certain auto-immune diseases (lupus, rheumatoid arthritis). It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It can reduce skin problems in lupus and prevent swelling/pain in arthritis. Hydroxychloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits.
11-Digit NDC Billing Format:
65841010312
Product Type:
Bulk Ingredient
Labeler Name:
Zydus Lifesciences Limited
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):
  • HYDROXYCHLOROQUINE SULFATE 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    09-27-2017
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 65841-103-12?

    The NDC Packaged Code 65841-103-12 is assigned to an UNFINISHED drug package of 1 bag in 1 drum / 1 bag in 1 bag / 1 bag in 1 bag / 35 kg in 1 bag of Hydroxychloroquine Sulfate, a bulk ingredient labeled by Zydus Lifesciences Limited. The product's dosage form is powder and is administered via form.

    Is NDC 65841-103 included in the NDC Directory?

    Yes, Hydroxychloroquine Sulfate is an UNFINISHED PRODUCT with code 65841-103 that is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on September 27, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65841-103-12?

    The 11-digit format is 65841010312. 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
    5-3-265841-103-125-4-265841-0103-12