Leukeran Tablet, Film Coated
NDC Package 80725-610-25

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

Package Information

Leukeran (chlorambucil) tablets is a medication used to treat certain types of cancer (such as leukemia, lymphoma). This formulation utilizes a tablet, film coated delivery system. Marketed by Waylis Therapeutics Llc, this product is identified by NDC 80725-610 and is authorized under FDA application NDA010669.

Identification & Billing

NDC Package Code
80725-610-25
Package Description
25 TABLET, FILM COATED in 1 BOTTLE
Product Code
80725-610
11-Digit Billing Format
80725061025
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
25 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leukeran
Non-Proprietary Name
Chlorambucil
Substance Name
Chlorambucil
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORAMBUCIL 2 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (such as leukemia, lymphoma). Chlorambucil belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Waylis Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA010669
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-15-2023
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 80725-610-25 identifies a specific commercial package of 25 tablet, film coated in 1 bottle of Leukeran, a human prescription drug labeled by Waylis Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 25 billable units per package. This tablet, film coated is formulated for oral use and contains chlorambucil 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 Waylis Therapeutics Llc on May 15, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (such as leukemia, lymphoma). Chlorambucil belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

How is this Waylis Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725061025. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 25 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)
80725-610-25
11-Digit CMS (5-4-2)
80725-0610-25

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