Hydroxychloroquine Sulfate Powder
NDC Package 67680-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Hydroxychloroquine Sulfate powders is hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. This formulation utilizes a powder delivery system. Marketed by Chongqing Kangle Pharmaceutical Co., Ltd., this product is identified by NDC 67680-003.

Identification & Billing

NDC Package Code
67680-003-01
Package Description
25 kg in 1 DRUM
Product Code
67680-003
11-Digit Billing Format
67680000301

Clinical Specifications

Proprietary Name
Hydroxychloroquine Sulfate
Non-Proprietary Name
Hydroxychloroquine Sulfate
Substance Name
Hydroxychloroquine Sulfate
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
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.

Regulatory & Marketing

Labeler Name
Chongqing Kangle Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-21-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67680-003-01 identifies a specific commercial package of 25 kg in 1 drum of Hydroxychloroquine Sulfate (UNFINISHED drug), a bulk ingredient labeled by Chongqing Kangle Pharmaceutical Co., Ltd.. This powder is formulated for use and contains hydroxychloroquine 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 Chongqing Kangle Pharmaceutical Co., Ltd. on November 21, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Chongqing Kangle Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67680000301. 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)
67680-003-01
11-Digit CMS (5-4-2)
67680-0003-01

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