Ameluz Gel
NDC Package 70621-101-30

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

Ameluz (aminolevulinic acid hydrochloride) gel is aMELUZ® gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED® lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. This formulation utilizes a gel delivery system. Marketed by Biofrontera Inc., this product is identified by NDC 70621-101 and is authorized under FDA application NDA208081.

Identification & Billing

NDC Package Code
70621-101-30
Package Description
1 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-03)
Product Code
70621-101
11-Digit Billing Format
70621010130
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
2 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ameluz
Non-Proprietary Name
Aminolevulinic Acid Hydrochloride
Substance Name
Aminolevulinic Acid Hydrochloride
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)
AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g
Pharmacologic Class
Usage Information
AMELUZ® gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED® lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

Regulatory & Marketing

Labeler Name
Biofrontera Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208081
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-26-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (70621-101). Click a package code to view its specific billing and regulatory data.

70621-101-10
1 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-01)
70621-101-20
10 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-01)

* 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 70621-101-30 identifies a specific commercial package of 1 tube in 1 package / 2 g in 1 tube (70621-101-03) of Ameluz, a human prescription drug labeled by Biofrontera Inc.. This product is billed per "GM" gram and contains an estimated amount of 2 billable units per package. This gel is formulated for topical 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 Biofrontera Inc. on August 26, 2016. The current certification is valid through December 31, 2026.

How is this Biofrontera Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70621010130. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 2 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)
70621-101-30
11-Digit CMS (5-4-2)
70621-0101-30

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