Urea
NDC Package 42192-101-10

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 discontinued by the firm.

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 Acella Pharmaceuticals, this product is identified by NDC 42192-101.

Identification & Billing

NDC Package Code
42192-101-10
Package Description
283.5 g in 1 TUBE
Product Code
42192-101
11-Digit Billing Format
42192010110
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
283.5 GM

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
Acella Pharmaceuticals
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
06-29-2009
End Marketing Date
05-31-2018
Listing Expiration
05-31-2018
Exclude Flag
D
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 42192-101-10 identifies a specific commercial package of 283.5 g in 1 tube of Urea, labeled by Acella Pharmaceuticals. This product is billed per "GM" gram and contains an estimated amount of 283.5 billable units per package. 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 Acella Pharmaceuticals on June 29, 2009. The current certification is valid through May 31, 2018.

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 Acella Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42192010110. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 283.5 total billable units per package. 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)
42192-101-10
11-Digit CMS (5-4-2)
42192-0101-10

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