Hydroxychloroquine Sulfate
NDC Package 42291-320-18
Package Information
Hydroxychloroquine Sulfate is hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. Marketed by Avkare, Inc., this product is identified by NDC 42291-320 and is authorized under FDA application ANDA040133.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 42291 - Avkare, Inc.
- 42291-320 - Hydroxychloroquine Sulfate
- 42291-320-18 - 180 TABLET in 1 BOTTLE
- 42291-320 - Hydroxychloroquine Sulfate
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (42291-320). Click a package code to view its specific billing and regulatory data.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 42291-320-18 identifies a specific commercial package of 180 tablet in 1 bottle of Hydroxychloroquine Sulfate, labeled by Avkare, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. 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 Avkare, Inc. on February 29, 2012. The current certification is valid through November 04, 2015.
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 Avkare, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291032018. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.