Plaquenil
NDC Package 42291-335-90

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

Plaquenil is hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. Marketed by Avkare, Inc., this product is identified by NDC 42291-335 and is authorized under FDA application NDA009768.

Identification & Billing

NDC Package Code
42291-335-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
42291-335
11-Digit Billing Format
42291033590

Clinical Specifications

Proprietary Name
Plaquenil
Dosage Form
-
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
Avkare, Inc.
FDA Application #
NDA009768
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-14-2016
End Marketing Date
03-31-2019
Listing Expiration
03-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-335-90 identifies a specific commercial package of 90 tablet in 1 bottle of Plaquenil, labeled by Avkare, Inc.. 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 July 14, 2016. The current certification is valid through March 31, 2019.

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: 42291033590. 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)
42291-335-90
11-Digit CMS (5-4-2)
42291-0335-90

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