NDC Package 61344-455-50 Uremol 20% Cream

Urea Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

61344-455-50

Package Description:

225 g in 1 TUBE

Product Code:

61344-455

Proprietary Name:

Uremol 20% Cream

Non-Proprietary Name:

Urea

Substance Name:

Urea

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.

11-Digit NDC Billing Format:

61344045550

NDC to RxNorm Crosswalk:

RxCUI: 198886 - urea 20 % Topical Cream

RxCUI: 198886 - urea 200 MG/ML Topical Cream

RxCUI: 198886 - urea 17 GM in 85 GM Topical Cream

Product Type:

Human Otc Drug

Labeler Name:

Odan Laboratories Ltd

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(s):

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 200 mg/g

Sample Package:

Marketing Category:

UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Start Marketing Date:

05-31-2019

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

61344 - Odan Laboratories Ltd
- 61344-455 - Uremol 20% Cream
  - 61344-455-50 - 225 g in 1 TUBE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61344-455-25	100 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61344-455-50?

The NDC Packaged Code 61344-455-50 is assigned to a package of 225 g in 1 tube of Uremol 20% Cream, a human over the counter drug labeled by Odan Laboratories Ltd. The product's dosage form is cream and is administered via topical form.

Is NDC 61344-455 included in the NDC Directory?

Yes, Uremol 20% Cream with product code 61344-455 is active and included in the NDC Directory. The product was first marketed by Odan Laboratories Ltd on May 31, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61344-455-50?

The 11-digit format is 61344045550. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	61344-455-50	5-4-2	61344-0455-50

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