Urea
NDC Package 52191-351-08

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 Bowyn Labs, Llc, this product is identified by NDC 52191-351.

Identification & Billing

NDC Package Code
52191-351-08
Package Description
227 g in 1 BOTTLE, PLASTIC
Product Code
52191-351
11-Digit Billing Format
52191035108
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
227 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
Bowyn Labs, Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-12-2018
End Marketing Date
11-30-2020
Listing Expiration
11-30-2020
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 52191-351-08 identifies a specific commercial package of 227 g in 1 bottle, plastic of Urea, labeled by Bowyn Labs, Llc. This product is billed per "GM" gram and contains an estimated amount of 227 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 Bowyn Labs, Llc on April 12, 2018. The current certification is valid through November 30, 2020.

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 Bowyn Labs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52191035108. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 227 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)
52191-351-08
11-Digit CMS (5-4-2)
52191-0351-08

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