ameluz

Generic: aminolevulinic acid hydrochloride

Labeler: biofrontera inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ameluz
Generic Name aminolevulinic acid hydrochloride
Labeler biofrontera inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

aminolevulinic acid hydrochloride 100 mg/g

Manufacturer
Biofrontera Inc.

Identifiers & Regulatory

Product NDC 70621-101
Product ID 70621-101_ca974f80-1bb2-4932-a651-d085020a8b57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208081
Listing Expiration 2026-12-31
Marketing Start 2016-08-26

Pharmacologic Class

Classes
fluorescence contrast activity [moa] optical imaging agent [epc] porphyrin precursor [epc] porphyrinogens [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70621101
Hyphenated Format 70621-101

Supplemental Identifiers

RxCUI
1806645 1806650
UNII
V35KBM8JGR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ameluz (source: ndc)
Generic Name aminolevulinic acid hydrochloride (source: ndc)
Application Number NDA208081 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01)
  • 10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01)
  • 1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03)
source: ndc

Packages (3)

70621-101-10 1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01) 70621-101-20 10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01) 70621-101-30 1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03)

Ingredients (1)

aminolevulinic acid hydrochloride (100 mg/g)

Linked Drug Pages (1)

AMELUZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ca974f80-1bb2-4932-a651-d085020a8b57", "openfda": {"unii": ["V35KBM8JGR"], "rxcui": ["1806645", "1806650"], "spl_set_id": ["650daa9f-aeec-49ce-95b9-5fa20b988afd"], "manufacturer_name": ["Biofrontera Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (70621-101-10)  / 2 g in 1 TUBE (70621-101-01)", "package_ndc": "70621-101-10", "marketing_start_date": "20170601"}, {"sample": false, "description": "10 TUBE in 1 PACKAGE (70621-101-20)  / 2 g in 1 TUBE (70621-101-01)", "package_ndc": "70621-101-20", "marketing_start_date": "20210510"}, {"sample": true, "description": "1 TUBE in 1 PACKAGE (70621-101-30)  / 2 g in 1 TUBE (70621-101-03)", "package_ndc": "70621-101-30", "marketing_start_date": "20170601"}], "brand_name": "AMELUZ", "product_id": "70621-101_ca974f80-1bb2-4932-a651-d085020a8b57", "dosage_form": "GEL", "pharm_class": ["Fluorescence Contrast Activity [MoA]", "Optical Imaging Agent [EPC]", "Porphyrin Precursor [EPC]", "Porphyrinogens [CS]"], "product_ndc": "70621-101", "generic_name": "aminolevulinic acid hydrochloride", "labeler_name": "Biofrontera Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMELUZ", "active_ingredients": [{"name": "AMINOLEVULINIC ACID HYDROCHLORIDE", "strength": "100 mg/g"}], "application_number": "NDA208081", "marketing_category": "NDA", "marketing_start_date": "20160826", "listing_expiration_date": "20261231"}