Gastrodia Elata Peptide Hand Sanitizing
NDC Package 75449-1001-1

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.

Gastrodia Elata Peptide Hand Sanitizing is 1.Sanitary hand disinfection: Take the right amount of this product on the palm, both hands rub each other to make uniform coating on each part for 1 minute. Marketed by Tonghua Ren-sheng-yuan Biotechnology Co., Ltd, this product is identified by NDC 75449-1001 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
75449-1001-1
Package Description
500 mL in 1 BOTTLE
Product Code
75449-1001
11-Digit Billing Format
75449100101

Clinical Specifications

Proprietary Name
Gastrodia Elata Peptide Hand Sanitizing
Dosage Form
-
Usage Information
1.Sanitary hand disinfection: Take the right amount of this product on the palm, both hands rub each other to make uniform coating on each part for 1 minute. 2. Surgical hand antisepsis: After surgical hand washing, apply proper amount of this product evenly to the skin of the forearm and the lower third of the upper arm of both hands and rub for 3 to 5 minutes until dry.

Regulatory & Marketing

Labeler Name
Tonghua Ren-sheng-yuan Biotechnology Co., Ltd
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
04-24-2020
Listing Expiration
12-31-2021
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 75449-1001-1 identifies a specific commercial package of 500 ml in 1 bottle of Gastrodia Elata Peptide Hand Sanitizing, labeled by Tonghua Ren-sheng-yuan Biotechnology 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 Tonghua Ren-sheng-yuan Biotechnology Co., Ltd on April 24, 2020. The current certification is valid through December 31, 2021.

How is this Tonghua Ren-sheng-yuan Biotechnology Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75449100101. 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 (5-4-1)
75449-1001-1
11-Digit CMS (5-4-2)
75449-1001-01

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