1. Home
  2. Labeler Index
  3. Biofrontera Inc.
  4. 70621-101
  5. NDC Package Code: 70621-101-10 Ameluz

NDC Package 70621-101-10 Ameluz

Aminolevulinic Acid Hydrochloride Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70621-101-10
Package Description:
1 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-01)
Product Code:
70621-101
Proprietary Name:
Ameluz
Non-Proprietary Name:
Aminolevulinic Acid Hydrochloride
Substance Name:
Aminolevulinic Acid Hydrochloride
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.
11-Digit NDC Billing Format:
70621010110
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
2 GM
Product Type:
Human Prescription Drug
Labeler Name:
Biofrontera Inc.
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(s):
  • 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(es):
  • Fluorescence Contrast Activity - [MoA] (Mechanism of Action)
  • Optical Imaging Agent - [EPC] (Established Pharmacologic Class)
  • Porphyrin Precursor - [EPC] (Established Pharmacologic Class)
  • Porphyrinogens - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA208081
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-26-2016
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 70621-101-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    70621010110J7345Aminolevulinic acid, 10% gel10 MG21200200

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70621-101-2010 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-01)
    70621-101-301 TUBE in 1 PACKAGE / 2 g in 1 TUBE (70621-101-03)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70621-101-10?

    The NDC Packaged Code 70621-101-10 is assigned to a package of 1 tube in 1 package / 2 g in 1 tube (70621-101-01) of Ameluz, a human prescription drug labeled by Biofrontera Inc.. The product's dosage form is gel and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 2 billable units per package.

    Is NDC 70621-101 included in the NDC Directory?

    Yes, Ameluz with product code 70621-101 is active and included in the NDC Directory. The product was first marketed by Biofrontera Inc. on August 26, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 70621-101-10?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 2.

    What is the 11-digit format for NDC 70621-101-10?

    The 11-digit format is 70621010110. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270621-101-105-4-270621-0101-10