Package 70621-101-10
Brand: ameluz
Generic: aminolevulinic acid hydrochloridePackage Facts
Identity
Package NDC
70621-101-10
Digits Only
7062110110
Product NDC
70621-101
Description
1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01)
Marketing
Marketing Status
Brand
ameluz
Generic
aminolevulinic acid hydrochloride
Sample Package
No
Linked Drug Pages (1)
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"}