Devolver Premium Gel
NDC Package 75001-201-07

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.

Devolver Premium Gel is wet hands thoroughly with product and allow to dry without wiping.For children under 6, use only under adult supervision. Marketed by Devolver Cosmetics Co., Ltd, this product is identified by NDC 75001-201 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
75001-201-07
Package Description
350 mL in 1 BOTTLE
Product Code
75001-201
11-Digit Billing Format
75001020107
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Devolver Premium Gel
Dosage Form
-
Usage Information
Wet hands thoroughly with product and allow to dry without wiping.For children under 6, use only under adult supervision.

Regulatory & Marketing

Labeler Name
Devolver Cosmetics 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
05-08-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75001-201). Click a package code to view its specific billing and regulatory data.

75001-201-01
60 mL in 1 BOTTLE
75001-201-02
100 mL in 1 BOTTLE
75001-201-03
236 mL in 1 BOTTLE, PUMP
75001-201-04
500 mL in 1 BOTTLE, PUMP
75001-201-05
3785 mL in 1 BOTTLE
75001-201-06
120 mL in 1 BOTTLE
75001-201-08
300 mL in 1 BOTTLE

* 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 75001-201-07 identifies a specific commercial package of 350 ml in 1 bottle of Devolver Premium Gel, labeled by Devolver Cosmetics 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 Devolver Cosmetics Co., Ltd on May 08, 2020. The current certification is valid through December 31, 2021.

How is this Devolver Cosmetics Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75001020107. 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)
75001-201-07
11-Digit CMS (5-4-2)
75001-0201-07

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