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United States · US · US:70621-101_ca974f80-1bb2-4932-a651-d085020a8b57
AMELUZ
Orange BookUNIISPLATC L01XD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiofrontera Inc.
CountryUS (United States)
ATC codeL01XD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170621101101 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01)
- ndc11706211012010 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01)
- ndc1170621101301 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03)
Annotations
UNII (FDA Substance ID)
V35KBM8JGR
AMINOLEVULINIC ACID HYDROCHLORIDE
RxCUI 261715
Orange Book
N208081
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V35KBM8JGR",
"rxcui": "261715",
"inchikey": "ZLHFONARZHCSET-UHFFFAOYSA-N",
"display_name": "AMINOLEVULINIC ACID HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"650daa9f-aeec-49ce-95b9-5fa20b988afd": {
"match": "brand_token",
"title": "AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE) GEL [BIOFRONTERA INC.]",
"spl_version": "31",
"published_date": "2025-12-23"
}
},
"productid": "70621-101_ca974f80-1bb2-4932-a651-d085020a8b57",
"productndc": "70621-101",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "208081",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10%",
"product_no": "001",
"approval_date": "May 10, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMINOLEVULINIC ACID HYDROCHLORIDE",
"proprietary_name": "AMELUZ",
"active_ingred_unit": "mg/g",
"application_number": "NDA208081",
"marketing_category": "NDA",
"nonproprietary_name": "aminolevulinic acid hydrochloride",
"start_marketing_date": "20160826",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01XD04.
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