Urea Cream 40% Cream
NDC Package 16477-340-01

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

Urea Cream 40% (urea) cream 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 cream delivery system. Marketed by Laser Pharmaceuticals, Llc, this product is identified by NDC 16477-340.

Identification & Billing

NDC Package Code
16477-340-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 28.35 g in 1 BOTTLE, PLASTIC
Product Code
16477-340
11-Digit Billing Format
16477034001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
28.35 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Urea Cream 40%
Non-Proprietary Name
Urea
Substance Name
Urea
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
UREA 400 mg/g
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
Laser Pharmaceuticals, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-04-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 (16477-340). Click a package code to view its specific billing and regulatory data.

16477-340-03
1 BOTTLE, PLASTIC in 1 CARTON / 85 g in 1 BOTTLE, PLASTIC
16477-340-07
1 BOTTLE, PLASTIC in 1 CARTON / 198.4 g in 1 BOTTLE, PLASTIC

* 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 16477-340-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 28.35 g in 1 bottle, plastic of Urea Cream 40%, a human prescription drug labeled by Laser Pharmaceuticals, Llc. This cream is formulated for topical 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 Laser Pharmaceuticals, Llc on May 04, 2018. 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 Laser Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16477034001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 28.35 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)
16477-340-01
11-Digit CMS (5-4-2)
16477-0340-01

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