Envirosolutions Sanitizing Wipes
NDC Package 64646-400-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Envirosolutions Sanitizing Wipes is • Open the plastic tab at the front of the bottle. Marketed by Charlotte Products Ltd., this product is identified by NDC 64646-400 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
64646-400-01
Package Description
343 mL in 1 CANISTER
Product Code
64646-400
11-Digit Billing Format
64646040001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Envirosolutions Sanitizing Wipes
Dosage Form
-
Usage Information
• Open the plastic tab at the front of the bottle. Pull up wipe and replace plastic cap. Always snap lid securely shut between uses to prevent moisture loss.• Take one wipe and rub onto hands to cover all surfaces. Let hands air dry.• NOT intended for intimate hygiene. Dispose of used wipes in trash.• Supervise children under 6 years of age when using this product to avoid swallowing.

Regulatory & Marketing

Labeler Name
Charlotte Products 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
02-01-2021
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64646-400). Click a package code to view its specific billing and regulatory data.

64646-400-02
1000 mL in 1 CANISTER

* 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 64646-400-01 identifies a specific commercial package of 343 ml in 1 canister of Envirosolutions Sanitizing Wipes, labeled by Charlotte Products 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 Charlotte Products Ltd. on February 01, 2021. The current certification is valid through December 31, 2022.

How is this Charlotte Products Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64646040001. 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)
64646-400-01
11-Digit CMS (5-4-2)
64646-0400-01

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