United States· US:71558-590_fd0780a6-2a99-45b5-892f-de92d09b3526
ARIKAYCE
A medicinal product containing amikacin, registered in United States by Insmed Incorporated.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- AMIKACIN
- Manufacturer
- Insmed Incorporated
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 9, 2026
Packs & prices · 1
- ndc1171558-590-28
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Amikacin in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAMIKACIN B. BRAUNB. Braun Melsungen AG, Melsungen
- United KingdomAmikacin 2.5% eye drops preservative freeSpecial Order
- BelgiumAmikacine B. Braun 10 mg/mlB. Braun Melsungen
- PolandAmikacin AdamedAdamed Pharma S.A.
- ItalyAMIKACINA TEVATEVA ITALIA S.R.L.
- SpainAMICACINA B BRAUN 10 mg/ml SOLUCION PARA PERFUSION INTRAVENOSAB Braun Medical S.A.
- FinlandAmikacin Afortas2Care4 Generics ApS
- FranceAMIKACINE PANPHARMA 250 mg/mL, solution injectablePANMEDICA
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Amikacin B. Braun
- Belgium · Amikacine B. Braun, Amikacine Fresenius Kabi
- Bulgaria · Amikacin Kabi, Амикацин Б. Браун
- Cyprus · Amika-Synto, Amikacin Vioser
- Czechia · Amikacin B. Braun, Amikacin Fresenius Kabi
- Germany · Amikacin B. Braun, Amikacin Eberth
- Denmark · Amikacin Afortas, Amikacin Macure
- Estonia · Amikacin B. Braun
- Spain · Amicacina, Amicacina B. Braun
- Finland · Amikacin Afortas, Amikacin Macure
- France · Amikacine B. Braun, Amikacine Kabi
- United Kingdom (Northern Ireland) · Amikacin Demo Pharma Uk, Amikacin Galvany Pharma
- Greece · Amicasil, Amikacin Anfarm
- Croatia · Amikacin Zentiva
- Hungary · Amikacin Anfarm, Amikacin B. Braun
- Ireland · Amikacin, Amikacin Athlone Pharmaceuticals
- Iceland · Arikayce Liposomal
- Italy · Amicasil, Amikacina B. Braun
- Liechtenstein · Arikayce Liposomal
- Lithuania · Biodacyna
- Luxembourg · Amikacin B. Braun, Amukin
- Latvia · Amikacin B.Braun
- Malta · Amikacin Tillomed Laboratories, Uzix
- Netherlands · Amikacine Hospira
- Norway · Amikacin Afortas, Amikacin Macure
- Poland · Amikacin B. Braun, Amikacin Kabi,
- Portugal · Amicacina Hikma, Amicacina Kabi
- Romania · Amikacin Noridem, Amikacină Atb
- Sweden · Amikacin Afortas, Amikacin Fresenius Kabi
- Slovenia · Amikacin Kabi
- Slovakia · Amikacin B. Braun, Amikacin Fresenius Kabi
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/cd3314ea-352e-4ca1-908e-1858dd4c781e GET /v1/drugs/cd3314ea-352e-4ca1-908e-1858dd4c781e?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": "RESPIRATORY (INHALATION)",
"source": "ndc",
"strength": "590",
"substance": "AMIKACIN",
"productndc": "71558-590",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/8.4mL",
"application_number": "NDA207356",
"marketing_category": "NDA"
}See everything about amikacin.
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.