Veregen Ointment
NDC Package 62559-385-30

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

Veregen (sinecatechins) ointment is sinecatechins are used to treat warts on and around the genitals and anus. This formulation utilizes a ointment delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 62559-385 and is authorized under FDA application NDA021902.

Identification & Billing

NDC Package Code
62559-385-30
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
62559-385
11-Digit Billing Format
62559038530
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Veregen
Non-Proprietary Name
Sinecatechins
Substance Name
Sinecatechins
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
SINECATECHINS 150 mg/g
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
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021902
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-10-2022
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 (62559-385). Click a package code to view its specific billing and regulatory data.

62559-385-26
6 CARTON in 1 CARTON / 1 TUBE in 1 CARTON (62559-385-02) / 2 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 62559-385-30 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Veregen, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This ointment is formulated for topical use and contains sinecatechins 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 Ani Pharmaceuticals, Inc. on November 10, 2022. The current certification is valid through December 31, 2026.

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 Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62559038530. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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)
62559-385-30
11-Digit CMS (5-4-2)
62559-0385-30

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