Zinc Pyrithione Shampoo
NDC Package 70533-003-14

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

Package Information

Zinc Pyrithione shampoos is • for best results use at least twice a week or as directed by a doctor. This formulation utilizes a shampoo delivery system. Marketed by Harry's Inc., this product is identified by NDC 70533-003 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
70533-003-14
Package Description
414 mL in 1 BOTTLE
Product Code
70533-003
11-Digit Billing Format
70533000314
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zinc Pyrithione
Non-Proprietary Name
Zinc Pyrithione
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 10 mg/mL
Usage Information
• for best results use at least twice a week or as directed by a doctor. • shake before use. • wet hair, massage onto scalp, rinse, repeat if desired.

Regulatory & Marketing

Labeler Name
Harry's Inc.
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2020
End Marketing Date
10-01-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70533-003). Click a package code to view its specific billing and regulatory data.

70533-003-02
59 mL in 1 TUBE

* 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 70533-003-14 identifies a specific commercial package of 414 ml in 1 bottle of Zinc Pyrithione, a human over the counter drug labeled by Harry's 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 Harry's Inc. on October 01, 2020.

How is this Harry's Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70533000314. 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)
70533-003-14
11-Digit CMS (5-4-2)
70533-0003-14

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