Truly Clean
NDC Package 78022-101-04

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.

Truly Clean is wet hands thoroughly with product and allow to dry without wiping. Marketed by Infuse Into Being Llc, this product is identified by NDC 78022-101 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
78022-101-04
Package Description
70 mL in 1 BOTTLE
Product Code
78022-101
11-Digit Billing Format
78022010104
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Truly Clean
Dosage Form
-
Usage Information
Wet hands thoroughly with product and allow to dry without wiping. Do not use other than directed.

Regulatory & Marketing

Labeler Name
Infuse Into Being Llc
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
05-26-2020
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 78022-101-04 identifies a specific commercial package of 70 ml in 1 bottle of Truly Clean, labeled by Infuse Into Being Llc. 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 Infuse Into Being Llc on May 26, 2020. The current certification is valid through December 31, 2021.

How is this Infuse Into Being Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78022010104. 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)
78022-101-04
11-Digit CMS (5-4-2)
78022-0101-04

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