Reearth Hand Sanitizer
NDC Package 77368-021-01

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.

Reearth Hand Sanitizer is wet hands thoroughly with the product to cover all surfaces. Marketed by Nugentec, this product is identified by NDC 77368-021 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
77368-021-01
Package Description
3786 mL in 1 CANISTER
Product Code
77368-021
11-Digit Billing Format
77368002101

Clinical Specifications

Proprietary Name
Reearth Hand Sanitizer
Dosage Form
-
Usage Information
Wet hands thoroughly with the product to cover all surfaces. Allow to dry without wiping.Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Nugentec
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
03-30-2020
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 77368-021-01 identifies a specific commercial package of 3786 ml in 1 canister of Reearth Hand Sanitizer, labeled by Nugentec. 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 Nugentec on March 30, 2020. The current certification is valid through December 31, 2021.

How is this Nugentec product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77368002101. 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)
77368-021-01
11-Digit CMS (5-4-2)
77368-0021-01

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