Gene 16 Whitening Factor Tablet, Soluble
NDC Package 69764-001-10

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

Package Information

Gene 16 Whitening Factor (allantoin) tablets is a medication used as Allantoin    Skin Lightener                 Skin Protectant. This formulation utilizes a tablet, soluble delivery system. Marketed by Shanghai Liangliang Bio Technology Co., Ltd, this product is identified by NDC 69764-001 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
69764-001-10
Package Description
1 POUCH in 1 PACKAGE / 7 mg in 1 POUCH
Product Code
69764-001
11-Digit Billing Format
69764000110

Clinical Specifications

Proprietary Name
Gene 16 Whitening Factor
Non-Proprietary Name
Allantoin
Substance Name
Allantoin
Dosage Form
Tablet, Soluble - A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.
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)
ALLANTOIN .5 mg/100mg
Usage Information
This product is used as Allantoin    Skin Lightener                 Skin Protectant

Regulatory & Marketing

Labeler Name
Shanghai Liangliang Bio Technology Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-25-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69764-001-10 identifies a specific commercial package of 1 pouch in 1 package / 7 mg in 1 pouch of Gene 16 Whitening Factor, a human over the counter drug labeled by Shanghai Liangliang Bio Technology Co., Ltd. This tablet, soluble is formulated for topical use and contains allantoin 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 Shanghai Liangliang Bio Technology Co., Ltd on September 25, 2014. The current certification is valid through December 31, 2027.

How is this Shanghai Liangliang Bio Technology Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69764000110. 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)
69764-001-10
11-Digit CMS (5-4-2)
69764-0001-10

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