1% Ketoconazole Anti Dandruff
NDC Package 84558-005-01

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 inactivated by the FDA.

1% Ketoconazole Anti Dandruff is adults and children 12 years and over：①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Marketed by Guangzhou Yusong Fine Chemicls Co., Ltd, this product is identified by NDC 84558-005 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
84558-005-01
Package Description
200 mL in 1 BOTTLE
Product Code
84558-005
11-Digit Billing Format
84558000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
1% Ketoconazole Anti Dandruff
Dosage Form
-
Usage Information
Adults and children 12 years and over：①wet hair thoroughly ②apply shampoo, generously lather, rinse thoroughly. Repeat ③use every 3-4 days for up to 8 weeks or as directed by a doctor,' Then use only as needed to control dandruff children under 12 years： ask a doctor

Regulatory & Marketing

Labeler Name
Guangzhou Yusong Fine Chemicls Co., Ltd
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-04-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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 84558-005-01 identifies a specific commercial package of 200 ml in 1 bottle of 1% Ketoconazole Anti Dandruff, labeled by Guangzhou Yusong Fine Chemicls Co., Ltd. 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 Guangzhou Yusong Fine Chemicls Co., Ltd on December 04, 2024. The current certification is valid through December 31, 2025.

How is this Guangzhou Yusong Fine Chemicls Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84558000501. 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)
84558-005-01
11-Digit CMS (5-4-2)
84558-0005-01

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