Leukeran
NDC Package 76388-635-25

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.

Leukeran is a medication used to treat certain types of cancer (such as leukemia, lymphoma). Marketed by Aspen Global Inc., this product is identified by NDC 76388-635 and is authorized under FDA application NDA010669.

Identification & Billing

NDC Package Code
76388-635-25
Package Description
25 TABLET, FILM COATED in 1 BOTTLE
Product Code
76388-635
11-Digit Billing Format
76388063525
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
25 EA

Clinical Specifications

Proprietary Name
Leukeran
Dosage Form
-
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
Aspen Global Inc.
FDA Application #
NDA010669
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-13-1985
End Marketing Date
09-30-2023
Listing Expiration
09-30-2023
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 (76388-635). Click a package code to view its specific billing and regulatory data.

76388-635-50
50 TABLET, FILM COATED in 1 BOTTLE

* 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 76388-635-25 identifies a specific commercial package of 25 tablet, film coated in 1 bottle of Leukeran, labeled by Aspen Global 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 Aspen Global Inc. on February 13, 1985. The current certification is valid through September 30, 2023.

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 Aspen Global Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76388063525. 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)
76388-635-25
11-Digit CMS (5-4-2)
76388-0635-25

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