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United States· US:70621-101_125f661a-bd21-41b9-bf5e-470ebf0216f6

AMELUZ

A aminolevulinic acid product containing aminolevulinic acid hydrochloride, registered in United States by Biofrontera Inc.. The same ATC class is registered in 14 of our 19 countries.

ATC L01XD04

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAMELUZATCL01XD04REGISTER NO.US:70621-101_125f661a…PACKS LISTED3CHECKEDAugust 23, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about aminolevulinic acid hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Aminolevulinic acid is registered in 14 of 19 countries.

Countries holding a registration under ATC L01XD04 (aminolevulinic acid), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose
Search aminolevulinic acid products by name

Aminolevulinic acid · ATC L01XD04

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMINOLEVULINIC ACID HYDROCHLORIDE
Manufacturer
Biofrontera Inc.
Country
United States (US)
ATC code
L01XD04
ATC class
Aminolevulinic acid
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 23, 2026

Packs & prices · 3

  • ndc11
    70621-101-10
  • ndc11
    70621-101-20
  • ndc11
    70621-101-30

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

121 interactions on record for aminolevulinic acid.

Graded by severity as the source publishes them — 120 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check aminolevulinic acid against other medicinesHow interaction checks work

Aminolevulinic acid · interactions on record

121 records

  • 120 severe
  • 1 moderate

Most severe, free to view

  • MinocyclineA01AB23severe
  • SulfasalazineA07EC01severe
  • GlibenclamideA10BB01severe
  • ChlorpropamideA10BB02severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Aminolevulinic acid in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All aminolevulinic acid products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Austria · Alacare
  • Belgium · Effala
  • Czechia · Alacare
  • Germany · Alacare
  • Denmark · Alacare
  • Finland · Alacare
  • France · Effala
  • United Kingdom (Northern Ireland) · Alacare
  • Ireland · Alacare
  • Iceland · Ameluz, Gliolan
  • Italy · Alacare
  • Liechtenstein · Ameluz, Gliolan
  • Netherlands · Alacare
  • Norway · Alacare, Ameluz
  • Poland · Alacare
  • Portugal · Alacare
  • Sweden · Alacare
  • Slovakia · Alacare

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/d71a35de-5ded-4c26-8aef-499c9ccf839d
GET /v1/drugs/d71a35de-5ded-4c26-8aef-499c9ccf839d?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "TOPICAL",
  "source": "ndc",
  "strength": "100",
  "substance": "AMINOLEVULINIC ACID HYDROCHLORIDE",
  "productndc": "70621-101",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "strength_unit": "mg/g",
  "application_number": "NDA208081",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about aminolevulinic acid.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

Try it freeOpen in the console