Valchlor Gel
NDC Package 69639-120-01

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

Package Information

Valchlor (mechlorethamine hydrochloride) gel is a medication used on the skin to treat a certain type of cancer (cutaneous T-cell lymphoma). This formulation utilizes a gel delivery system. Marketed by Helsinn Therapeutics (u.s.), Inc., this product is identified by NDC 69639-120 and is authorized under FDA application NDA202317.

Identification & Billing

NDC Package Code
69639-120-01
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
69639-120
11-Digit Billing Format
69639012001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valchlor
Non-Proprietary Name
Mechlorethamine Hydrochloride
Substance Name
Mechlorethamine
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
MECHLORETHAMINE .012 g/60g
Pharmacologic Class
Usage Information
This medication is used on the skin to treat a certain type of cancer (cutaneous T-cell lymphoma). Mechlorethamine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells that cause the skin condition.

Regulatory & Marketing

Labeler Name
Helsinn Therapeutics (u.s.), Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202317
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-08-2018
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 69639-120-01 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Valchlor, a human prescription drug labeled by Helsinn Therapeutics (u.s.), Inc.. This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package. This gel is formulated for topical use and contains mechlorethamine 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 Helsinn Therapeutics (u.s.), Inc. on November 08, 2018. 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 a certain type of cancer (cutaneous T-cell lymphoma). Mechlorethamine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells that cause the skin condition.

How is this Helsinn Therapeutics (u.s.), Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69639012001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 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)
69639-120-01
11-Digit CMS (5-4-2)
69639-0120-01

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