United States· US:67184-0570_0a56f2df-a71f-44a1-b7d0-98ee44e30e80

Amikacin Sulfate

A medicinal product containing amikacin sulfate, registered in United States by Qilu Pharmaceutical Co., Ltd..

US label

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAmikacin SulfateATC—REGISTER NO.US:67184-0570_0a56f2d…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMIKACIN SULFATE
Manufacturer
Qilu Pharmaceutical Co., Ltd.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    67184-0570-2
  • ndc11
    6718405702
    10 VIAL, GLASS in 1 CARTON (67184-0570-2) / 4 mL in 1 VIAL, GLASS (67184-0570-1)

Regulatory notes

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

Same medicine, other countries

Amikacin sulfate in 16 other countries

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

All amikacin sulfate products

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/dc31f9d3-67db-4336-8dc4-06c0c5f01ed7
GET /v1/drugs/dc31f9d3-67db-4336-8dc4-06c0c5f01ed7?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": "INTRAMUSCULAR; INTRAVENOUS",
  "source": "ndc",
  "strength": "250",
  "substance": "AMIKACIN SULFATE",
  "productndc": "67184-0570",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA218146",
  "marketing_category": "ANDA"
}

See everything about amikacin sulfate.

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.