United States· US:83853-101_c94eb0a9-2978-4fa6-9bc2-e02f7da94768
AQNEURSA
A levacetylleucine product containing levacetylleucine, registered in United States by IntraBio Inc. The same ATC class is registered in 7 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Levacetylleucine is registered in 7 of 19 countries.
Countries holding a registration under ATC N07XX27 (levacetylleucine), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 5 of them publish a price we can compare per daily dose
Levacetylleucine · ATC N07XX27
7 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LEVACETYLLEUCINE
- Manufacturer
- IntraBio Inc
- Country
- United States (US)
- ATC code
- N07XX27
- ATC class
- Levacetylleucine
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 1
- ndc1183853-101-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Levacetylleucine in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandAqneursaIntrabio Ireland Limited
- PolandAqneursaIntraBio Ireland Limited
- CzechiaAQNEURSAIntraBio Ireland Ltd., Dublin 2
- IrelandAqneursa 1 g granules for oral suspension in sachetIntrabio Ireland Limited
- IcelandAqneursaIntrabio Ireland Limited
- NetherlandsAqneursa 1 g granulaat voor orale suspensie in sachetIntrabio Ireland Limited
- SwedenAqneursa 1 g Granulat till oral lösning i dospåseIntrabio Ireland Limited
- BelgiumAqneursa 1 gIntraBio Ireland Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Aqneursa
- Liechtenstein · Aqneursa
- Norway · Aqneursa
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/e56e4206-bce6-4e85-b301-74f2bd74964f GET /v1/drugs/e56e4206-bce6-4e85-b301-74f2bd74964f?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": "ORAL",
"source": "ndc",
"strength": "1000",
"substance": "LEVACETYLLEUCINE",
"productndc": "83853-101",
"dosage_form": "GRANULE, FOR SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA219132",
"marketing_category": "NDA"
}See everything about levacetylleucine.
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.