Urea Cream 40%
NDC Package 80587-113-07

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Urea Cream 40% is a . Marketed by Prime Labs, Llc Dba Quality Cdmo, this product is identified by NDC 80587-113.

Identification & Billing

NDC Package Code
80587-113-07
Package Description
198.4 g in 1 BOTTLE
Product Code
80587-113
11-Digit Billing Format
80587011307

Clinical Specifications

Proprietary Name
Urea Cream 40%
Dosage Form
-

Regulatory & Marketing

Labeler Name
Prime Labs, Llc Dba Quality Cdmo
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-18-2021
End Marketing Date
09-27-2024
Listing Expiration
09-27-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80587-113). Click a package code to view its specific billing and regulatory data.

80587-113-01
28 g in 1 BOTTLE
80587-113-03
85 g in 1 BOTTLE

* 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 80587-113-07 identifies a specific commercial package of 198.4 g in 1 bottle of Urea Cream 40%, labeled by Prime Labs, Llc Dba Quality Cdmo. 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 Prime Labs, Llc Dba Quality Cdmo on November 18, 2021. The current certification is valid through September 27, 2024.

How is this Prime Labs, Llc Dba Quality Cdmo product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80587011307. 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)
80587-113-07
11-Digit CMS (5-4-2)
80587-0113-07

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