Xtracare Anti-dandruff Hair Cleanse Shampoo
NDC Package 57337-024-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Xtracare Anti-dandruff Hair Cleanse (pyrithione zinc) shampoos is Uses helps prevent recurrence of flaking and itching associated with dandruff.Gentle enough for everyday use. This formulation utilizes a shampoo delivery system. Marketed by Rejoice International Inc., this product is identified by NDC 57337-024 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
57337-024-01
Package Description
400 mg in 1 BOTTLE
Product Code
57337-024
11-Digit Billing Format
57337002401

Clinical Specifications

Proprietary Name
Xtracare Anti-dandruff Hair Cleanse Coconut And Shea Butter
Non-Proprietary Name
Pyrithione Zinc
Substance Name
Pyrithione Zinc
Dosage Form
Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
PYRITHIONE ZINC 20 mg/400mg
Usage Information
Uses helps prevent recurrence of flaking and itching associated with dandruff.Gentle enough for everyday use. For best results, use with XtraCare nourishing coconut & shea butter conditioner.

Regulatory & Marketing

Labeler Name
Rejoice International Inc.
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-09-2013
Listing Expiration
12-31-2026
Exclude Flag
N
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 57337-024-01 identifies a specific commercial package of 400 mg in 1 bottle of Xtracare Anti-dandruff Hair Cleanse Coconut And Shea Butter, a human over the counter drug labeled by Rejoice International Inc.. This shampoo is formulated for topical use and contains pyrithione zinc 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 Rejoice International Inc. on October 09, 2013. The current certification is valid through December 31, 2026.

How is this Rejoice International Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57337002401. 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)
57337-024-01
11-Digit CMS (5-4-2)
57337-0024-01

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