Tolak Cream
NDC Package 28105-421-40

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tolak (fluorouracil) cream is a medication used on the skin to treat pre-cancerous and cancerous skin growths. This formulation utilizes a cream delivery system. Marketed by Hill Dermaceuticals, Inc., this product is identified by NDC 28105-421 and is authorized under FDA application NDA022259.

Identification & Billing

NDC Package Code
28105-421-40
Package Description
1 TUBE in 1 CARTON / 40 g in 1 TUBE
Product Code
28105-421
11-Digit Billing Format
28105042140
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
40 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tolak
Non-Proprietary Name
Fluorouracil
Substance Name
Fluorouracil
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
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)
FLUOROURACIL .04 g/g
Pharmacologic Class
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
Hill Dermaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022259
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-18-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 28105-421-40 identifies a specific commercial package of 1 tube in 1 carton / 40 g in 1 tube of Tolak, a human prescription drug labeled by Hill Dermaceuticals, Inc.. This cream is formulated for topical use and contains fluorouracil 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 Hill Dermaceuticals, Inc. on September 18, 2015. The current certification is valid through December 31, 2026.

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 Hill Dermaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 28105042140. 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)
28105-421-40
11-Digit CMS (5-4-2)
28105-0421-40

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