Gliadel Wafer
NDC Package 24338-050-08

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

Package Information

Gliadel (carmustine) wafers is a medication used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). This formulation utilizes a wafer delivery system. Marketed by Azurity Pharmaceuticals, Inc., this product is identified by NDC 24338-050 and is authorized under FDA application NDA020637.

Identification & Billing

NDC Package Code
24338-050-08
Package Description
8 POUCH in 1 BOX / 1 WAFER in 1 POUCH
Product Code
24338-050
11-Digit Billing Format
24338005008
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
8 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gliadel
Non-Proprietary Name
Carmustine
Substance Name
Carmustine
Dosage Form
Wafer - A thin slice of material containing a medicinal agent.
Administration Route
Intracavitary - Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that which is formed as the result of a wound.
Active Ingredient(s)
CARMUSTINE 7.7 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). Carmustine 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
Azurity Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020637
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-13-2012
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 24338-050-08 identifies a specific commercial package of 8 pouch in 1 box / 1 wafer in 1 pouch of Gliadel, a human prescription drug labeled by Azurity Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 8 billable units per package. This wafer is formulated for intracavitary use and contains carmustine 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 Azurity Pharmaceuticals, Inc. on December 13, 2012. 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 (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). Carmustine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24338005008. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 8 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)
24338-050-08
11-Digit CMS (5-4-2)
24338-0050-08

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