United States· US:63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3

Polymyxin B

A medicinal product containing polymyxin b sulfate, registered in United States by Fresenius Kabi 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…normalisedPolymyxin BATC—REGISTER NO.US:63323-367_5cf9b65b…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
POLYMYXIN B SULFATE
Manufacturer
Fresenius Kabi 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 · 2

  • ndc11
    63323-367-44
  • ndc11
    6332336744
    10 VIAL, GLASS in 1 CARTON (63323-367-44) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (63323-367-41)

Regulatory notes

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

Same medicine, other countries

Polymyxin b sulfate in 3 other countries

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

All polymyxin b sulfate products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Germany · Polymyxin B Sulfat Smartpractice Europe

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/ee654d31-91c9-4d83-967c-4d916418ebe6
GET /v1/drugs/ee654d31-91c9-4d83-967c-4d916418ebe6?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; INTRATHECAL; INTRAVENOUS",
  "source": "ndc",
  "strength": "500000",
  "substance": "POLYMYXIN B SULFATE",
  "productndc": "63323-367",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "[USP'U]/1",
  "application_number": "ANDA202766",
  "marketing_category": "ANDA"
}

See everything about polymyxin b 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.