Urea
NDC Package 15631-0449-2

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.

Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). Marketed by Rxhomeo Private Limited D.b.a. Rxhomeo, Inc, this product is identified by NDC 15631-0449.

Identification & Billing

NDC Package Code
15631-0449-2
Package Description
400 PELLET in 1 PACKAGE
Product Code
15631-0449
11-Digit Billing Format
15631044902

Clinical Specifications

Proprietary Name
Urea
Dosage Form
-
Usage Information
Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

Regulatory & Marketing

Labeler Name
Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
10-31-2015
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 (15631-0449). Click a package code to view its specific billing and regulatory data.

15631-0449-0
100 PELLET in 1 VIAL, SINGLE-DOSE
15631-0449-1
200 PELLET in 1 PACKAGE
15631-0449-3
750 PELLET in 1 PACKAGE
15631-0449-4
2500 PELLET in 1 PACKAGE
15631-0449-5
12500 PELLET in 1 PACKAGE

* 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 15631-0449-2 identifies a specific commercial package of 400 pellet in 1 package of Urea, labeled by Rxhomeo Private Limited D.b.a. Rxhomeo, Inc. 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 Rxhomeo Private Limited D.b.a. Rxhomeo, Inc on October 31, 2015. The current certification is valid through December 31, 2021.

What are the primary indications for this medication?

Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

How is this Rxhomeo Private Limited D.b.a. Rxhomeo, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15631044902. 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)
15631-0449-2
11-Digit CMS (5-4-2)
15631-0449-02

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