Cysndra Ketoconazole 1% Medicated Shampoos Liquid
NDC Package 87681-014-01

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

Cysndra Ketoconazole 1% Medicated Shampoos (ketoconazole) liquids is a medication used to control dandruff. This formulation utilizes a liquid delivery system. Marketed by Guangzhou Xinhongda Trading Service Co., Ltd., this product is identified by NDC 87681-014 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
87681-014-01
Package Description
1 BOTTLE in 1 BOX / 300 mL in 1 BOTTLE
Product Code
87681-014
11-Digit Billing Format
87681001401

Clinical Specifications

Proprietary Name
Cysndra Ketoconazole 1% Medicated Shampoos
Non-Proprietary Name
Ketoconazole
Substance Name
Ketoconazole
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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)
KETOCONAZOLE .01 g/mL
Pharmacologic Class
Usage Information
This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs.

Regulatory & Marketing

Labeler Name
Guangzhou Xinhongda Trading Service Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-06-2026
Listing Expiration
12-31-2027
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 (87681-014). Click a package code to view its specific billing and regulatory data.

87681-014-02
1 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE

* 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 87681-014-01 identifies a specific commercial package of 1 bottle in 1 box / 300 ml in 1 bottle of Cysndra Ketoconazole 1% Medicated Shampoos, a human over the counter drug labeled by Guangzhou Xinhongda Trading Service Co., Ltd.. This liquid is formulated for topical use and contains ketoconazole 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 Guangzhou Xinhongda Trading Service Co., Ltd. on July 06, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs.

How is this Guangzhou Xinhongda Trading Service Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87681001401. 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)
87681-014-01
11-Digit CMS (5-4-2)
87681-0014-01

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