Keracare Dry And Itchy Scalp Anti-dandruff Lotion
NDC Package 63766-003-01

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

Keracare Dry And Itchy Scalp Anti-dandruff (pyrithione zinc) lotions is use for the relief of scalp flaking, itching and irritation associated withdandruff and seborrheic dermatitis. This formulation utilizes a lotion delivery system. Marketed by Avlon Industries, Inc., this product is identified by NDC 63766-003 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
63766-003-01
Package Description
240 mL in 1 TUBE
Product Code
63766-003
11-Digit Billing Format
63766000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Keracare Dry And Itchy Scalp Anti-dandruff
Non-Proprietary Name
Pyrithione Zinc
Substance Name
Pyrithione Zinc
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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
Use for the relief of scalp flaking, itching and irritation associated withdandruff and seborrheic dermatitis.

Regulatory & Marketing

Labeler Name
Avlon Industries, Inc.
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-18-2009
End Marketing Date
05-23-2027
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 (63766-003). Click a package code to view its specific billing and regulatory data.

63766-003-02
950 mL in 1 BOTTLE
63766-003-03
15 mL in 1 POUCH

* 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 63766-003-01 identifies a specific commercial package of 240 ml in 1 tube of Keracare Dry And Itchy Scalp Anti-dandruff, a human over the counter drug labeled by Avlon Industries, Inc.. This lotion 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 Avlon Industries, Inc. on June 18, 2009.

How is this Avlon Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63766000301. 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)
63766-003-01
11-Digit CMS (5-4-2)
63766-0003-01

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