Glutathione Soap
NDC Package 85164-001-01

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

Package Information

Glutathione (kojic acidskin lightening) soaps is classified as a

administered via topical route. This formulation utilizes a soap delivery system. Marketed by Hanchoyeanbiotec Co.,ltd., this product is identified by NDC 85164-001 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
85164-001-01
Package Description
100 g in 1 BOX
Product Code
85164-001
11-Digit Billing Format
85164000101

Clinical Specifications

Proprietary Name
Glutathione
Non-Proprietary Name
Kojic Acidskin Lightening
Substance Name
Alpha-arbutin; Ascorbic Acid; Glutathione; Tocopherol
Dosage Form
Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.
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)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Hanchoyeanbiotec Co.,ltd.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-17-2025
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 85164-001-01 identifies a specific commercial package of 100 g in 1 box of Glutathione, a human over the counter drug labeled by Hanchoyeanbiotec Co.,ltd.. This soap is formulated for topical use and contains alpha-arbutin; ascorbic acid; glutathione; tocopherol 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 Hanchoyeanbiotec Co.,ltd. on January 17, 2025. The current certification is valid through December 31, 2026.

How is this Hanchoyeanbiotec Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85164000101. 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)
85164-001-01
11-Digit CMS (5-4-2)
85164-0001-01

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