Urea Powder
NDC Package 14639-8432-2

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Urea powders is urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). This formulation utilizes a powder delivery system. Marketed by Merck Kgaa, this product is identified by NDC 14639-8432.

Identification & Billing

NDC Package Code
14639-8432-2
Package Description
1 kg in 1 BOTTLE, PLASTIC
Product Code
14639-8432
11-Digit Billing Format
14639843202

Clinical Specifications

Proprietary Name
Urea
Non-Proprietary Name
Urea
Substance Name
Urea
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
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
Merck Kgaa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-15-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (14639-8432). Click a package code to view its specific billing and regulatory data.

14639-8432-3
1 kg in 1 BOTTLE, PLASTIC
14639-8432-4
5 kg in 1 BOTTLE, PLASTIC
14639-8432-7
25 kg in 1 BOX

* 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 14639-8432-2 identifies a specific commercial package of 1 kg in 1 bottle, plastic of Urea (UNFINISHED drug), a bulk ingredient labeled by Merck Kgaa. This powder is formulated for use and contains urea as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Kgaa on June 15, 2016. The current certification is valid through December 31, 2026.

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 Merck Kgaa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14639843202. 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)
14639-8432-2
11-Digit CMS (5-4-2)
14639-8432-02

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