Gleolan Powder, For Solution
NDC Package 71469-231-01

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

Package Information

Gleolan (aminolevulinic acid hydrochloride) powders is gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. This formulation utilizes a powder, for solution delivery system. Marketed by Nx Development Corp, this product is identified by NDC 71469-231 and is authorized under FDA application NDA208630.

Identification & Billing

NDC Package Code
71469-231-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
71469-231
11-Digit Billing Format
71469023101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Gleolan
Non-Proprietary Name
Aminolevulinic Acid Hydrochloride
Substance Name
Aminolevulinic Acid Hydrochloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMINOLEVULINIC ACID HYDROCHLORIDE 1500 mg/1
Pharmacologic Class
Usage Information
Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.

Regulatory & Marketing

Labeler Name
Nx Development Corp
Product Type
Human Prescription Drug
FDA Application #
NDA208630
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-14-2018
Listing Expiration
12-31-2027
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 71469-231-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 powder, for solution in 1 vial, single-dose of Gleolan, a human prescription drug labeled by Nx Development Corp. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder, for solution is formulated for oral use and contains aminolevulinic acid hydrochloride 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 Nx Development Corp on March 14, 2018. The current certification is valid through December 31, 2027.

How is this Nx Development Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71469023101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
71469-231-01
11-Digit CMS (5-4-2)
71469-0231-01

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