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United States· US:65219-188_9acdebb0-6e88-42b2-ac45-da51aaad0f3c

ketamine hydrochloride

A ketamine product containing ketamine hydrochloride, registered in United States by Fresenius Kabi USA, LLC. The same ATC class is registered in 15 of our 19 countries.

ATC N01AX03US 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…normalisedketamine hydrochlorideATCN01AX03REGISTER NO.US:65219-188_9acdebb0…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Ketamine is registered in 15 of 19 countries.

Countries holding a registration under ATC N01AX03 (ketamine), 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

Ketamine · ATC N01AX03

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Ireland
  • Japan
  • Norwayprice
  • Polandprice
  • Sweden
  • 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
KETAMINE HYDROCHLORIDE
Manufacturer
Fresenius Kabi USA, LLC
Country
United States (US)
ATC code
N01AX03
ATC class
Ketamine
Defined daily dose
0.25 g, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    65219-188-10
  • ndc11
    6521918810
    10 VIAL in 1 TRAY (65219-188-10) / 10 mL in 1 VIAL (65219-188-01)

Regulatory notes

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

Interactions

145 interactions on record for ketamine.

Graded by severity as the source publishes them — 124 moderate. 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

Ketamine · interactions on record

145 records

  • 124 moderate
  • 21 info

Most severe, free to view

  • EpinephrineA01AD01moderate
  • IsomethepteneA03AX10moderate
  • MetoclopramideA03FA01moderate
  • ThiethylperazinA04AB03moderate
  • 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

Ketamine in 13 other countries

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

All ketamine products

Authorised across Europe · EMA

The same active substance is authorised in 21 EEA countries. Names it is sold under:

  • Austria · Ketamin G.L., Ketamin, Enthält Benzethoniumchlorid G.L.
  • Belgium · Ketalar
  • Bulgaria · Калипсол
  • Czechia · Calypsol
  • Germany · Ketamin, Ketamin Hameln
  • Denmark · Ketamin Abcur
  • Spain · Ketolar
  • Finland · Ketamin Abcur
  • France · Ketamine G.L. Pharma, Ketamine Panpharma
  • United Kingdom (Northern Ireland) · Ketalar, Ketamine
  • Hungary · Calypsol
  • Ireland · Ketalar
  • Italy · Ketamina Molteni
  • Luxembourg · Ketalar
  • Malta · Ketamine Hydrochloride Inresa
  • Norway · Ketalar, Ketamin Abcur
  • Poland · Ketalar
  • Portugal · Cetamina G.L. Pharma, Cetamina Hikma
  • Romania · Calypsol
  • Sweden · Ketalar, Ketamin Abcur
  • Slovakia · Calypsol

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/d1681650-a9a5-4e7e-8eb3-32150d7367db
GET /v1/drugs/d1681650-a9a5-4e7e-8eb3-32150d7367db?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": "50",
  "substance": "KETAMINE HYDROCHLORIDE",
  "productndc": "65219-188",
  "dosage_form": "INJECTION",
  "dea_schedule": "CIII",
  "strength_unit": "mg/mL",
  "application_number": "ANDA215808",
  "marketing_category": "ANDA"
}

See everything about ketamine.

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.