Ameluz Gel
NDC Package 70621-101-20
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
- RxCUI: 1806645 - aminolevulinic acid HCl 10 % Topical Gel
- RxCUI: 1806645 - aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel
- RxCUI: 1806645 - aminolevulinic acid hydrochloride 10 % Topical Gel
- RxCUI: 1806650 - Ameluz 10 % Topical Gel
- RxCUI: 1806650 - aminolevulinic acid hydrochloride 0.1 MG/MG Topical Gel [Ameluz]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 70621 - Biofrontera Inc.
- 70621-101 - Ameluz
- 70621-101-20 - 10 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-01)
- 70621-101 - Ameluz
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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.
* 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 70621-101-20 identifies a specific commercial package of 10 tube in 1 package / 2 g in 1 tube (70621-101-01) 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: 70621010120. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
