United States· US:70594-023_a1a2ccc4-a8e6-4161-aed6-a807c53b5e5e

Colistimethate

A medicinal product containing colistimethate sodium, registered in United States by Xellia Pharmaceuticals USA LLC.

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…normalisedColistimethateATC—REGISTER NO.US:70594-023_a1a2ccc4…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
COLISTIMETHATE SODIUM
Manufacturer
Xellia Pharmaceuticals USA LLC
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 · 4

  • ndc11
    7059402301
    1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    7059402304
    12 VIAL, GLASS in 1 CARTON (70594-023-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    70594-023-01
  • ndc11
    70594-023-04

Regulatory notes

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

Same medicine, other countries

Colistimethate sodium in 12 other countries

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

All colistimethate sodium products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Colifin, Colintens
  • Belgium · Colistimethate Sodium Accord, Colistimethate Sodium Noridem
  • Bulgaria · Колистиметат Натрий Акорд, Колистиметат Ромфарм
  • Cyprus · Colistimethate Sodium Accord
  • Czechia · Colistimethate Noridem, Colistimethate Olikla
  • Germany · Calistimethat-Natrium Sgs Pharma, Colifin
  • Denmark · Colistimethatnatrium Xellia, Kolistimetatnatrium Accord
  • Estonia · Colistimethate Sodium Accord, Colistimethate Sodium Auxilia
  • Spain · Colfinair, Colistimetato De Sodio Accord
  • Finland · Kolistimetatnatrium Noridem
  • France · Colistimethate Sodique Accord, Colistimethate Sodique Amdipharm
  • United Kingdom (Northern Ireland) · Colicym, Colistimethate Sodium Accord-Uk
  • Greece · Colistimethate Sodium Ariti, Colistin Norma
  • Croatia · Colixin, Kolistimetatnatrij Accord
  • Hungary · Colistimethate Sodium Accord, Colomycin
  • Ireland · Colistimethate Sodium Accord, Colistimethate Sodium Noridem Enterprises
  • Iceland · Colobreathe, Kólistímetat Natríum Xellia
  • Italy · Colfinair, Colistimetato Accord
  • Liechtenstein · Colobreathe
  • Lithuania · Colistimethate Sodium Accord, Colistimethate Sodium Auxilia
  • Luxembourg · Colistineb
  • Malta · Colistimethate Sodium Kent Pharma Uk, Colixin
  • Netherlands · Colifin, Colistimethaatnatrium Accord
  • Norway · Colobreathe, Kolistimetatnatrium Noridem
  • Poland · Colistimethate Accord, Colistimethatum Natricum Noridem
  • Portugal · Colistimetato Accord, Colistimetato Accordpharma
  • Romania · Colistimetat De Sodiu Accord, Colistimetat Rompharm
  • Sweden · Colineb, Kolistimetatnatrium Accord
  • Slovenia · Natrijev Kolistimetat Accord
  • Slovakia · Colistimethate Noridem, Colistimethate Olikla

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/8768e226-39d2-4d6b-baba-3c1a94a6f272
GET /v1/drugs/8768e226-39d2-4d6b-baba-3c1a94a6f272?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": "150",
  "substance": "COLISTIMETHATE SODIUM",
  "productndc": "70594-023",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA205356",
  "marketing_category": "ANDA"
}

See everything about colistimethate sodium.

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.