Tolak
NDC Package 64370-421-40

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.

Tolak is a medication used on the skin to treat pre-cancerous and cancerous skin growths. Marketed by Pierre Fabre Pharmaceuticals, Inc., this product is identified by NDC 64370-421 and is authorized under FDA application NDA022259.

Identification & Billing

NDC Package Code
64370-421-40
Package Description
1 TUBE in 1 CARTON / 40 g in 1 TUBE
Product Code
64370-421
11-Digit Billing Format
64370042140
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
40 GM

Clinical Specifications

Proprietary Name
Tolak
Dosage Form
-
Usage Information
This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Fluorouracil belongs to a class of medications known as anti-metabolites. It works by blocking the growth of abnormal cells that cause the skin condition.

Regulatory & Marketing

Labeler Name
Pierre Fabre Pharmaceuticals, Inc.
FDA Application #
NDA022259
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-15-2017
End Marketing Date
12-31-2020
Listing Expiration
12-31-2020
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 (64370-421). Click a package code to view its specific billing and regulatory data.

64370-421-83
8 CARTON in 1 CARTON / 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE (64370-421-03)

* 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 64370-421-40 identifies a specific commercial package of 1 tube in 1 carton / 40 g in 1 tube of Tolak, labeled by Pierre Fabre 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 Pierre Fabre Pharmaceuticals, Inc. on March 15, 2017. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Fluorouracil belongs to a class of medications known as anti-metabolites. It works by blocking the growth of abnormal cells that cause the skin condition.

How is this Pierre Fabre Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64370042140. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 40 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)
64370-421-40
11-Digit CMS (5-4-2)
64370-0421-40

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