Veregen
NDC Package 10337-450-08

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.

Veregen is sinecatechins are used to treat warts on and around the genitals and anus. Marketed by Pharmaderm A Division Of Fougera Pharmaceuticals Inc., this product is identified by NDC 10337-450 and is authorized under FDA application NDA021902.

Identification & Billing

NDC Package Code
10337-450-08
Package Description
1 TUBE in 1 CARTON / 2 g in 1 TUBE
Product Code
10337-450
11-Digit Billing Format
10337045008

Clinical Specifications

Proprietary Name
Veregen
Dosage Form
-
Usage Information
Sinecatechins are used to treat warts on and around the genitals and anus. These warts are caused by the human papillomavirus (HPV). Sinecatechins are natural substances found in certain green tea leaves. It is not known how this medication works. This medication does not cure warts, but it may help the infection clear faster. New warts may occur during or after treatment. This medication does not prevent the spread of warts through sexual contact, and it may weaken condoms and diaphragms. Talk to your doctor about safer sex practices.

Regulatory & Marketing

Labeler Name
Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
FDA Application #
NDA021902
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-14-2007
End Marketing Date
10-31-2022
Listing Expiration
10-31-2022
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 (10337-450). Click a package code to view its specific billing and regulatory data.

10337-450-03
1 TUBE in 1 CARTON / 30 g in 1 TUBE
10337-450-15
1 TUBE in 1 CARTON / 15 g in 1 TUBE
10337-450-99
1 TUBE in 1 CARTON / 4 g in 1 TUBE

* 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 10337-450-08 identifies a specific commercial package of 1 tube in 1 carton / 2 g in 1 tube of Veregen, labeled by Pharmaderm A Division Of Fougera Pharmaceuticals Inc.. 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 Pharmaderm A Division Of Fougera Pharmaceuticals Inc. on December 14, 2007. The current certification is valid through October 31, 2022.

What are the primary indications for this medication?

Sinecatechins are used to treat warts on and around the genitals and anus. These warts are caused by the human papillomavirus (HPV). Sinecatechins are natural substances found in certain green tea leaves. It is not known how this medication works. This medication does not cure warts, but it may help the infection clear faster. New warts may occur during or after treatment. This medication does not prevent the spread of warts through sexual contact, and it may weaken condoms and diaphragms. Talk to your doctor about safer sex practices.

How is this Pharmaderm A Division Of Fougera Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10337045008. 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)
10337-450-08
11-Digit CMS (5-4-2)
10337-0450-08

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