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United States· US:70594-049_fda91987-b6cd-4233-b09c-0f0300ad5df2

Polymyxin B

A polymyxin b product containing polymyxin b sulfate, registered in United States by Xellia Pharmaceuticals USA LLC.

ATC J01XB02Orange BookUS 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 BATCJ01XB02REGISTER NO.US:70594-049_fda91987…PACKS LISTED2CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about polymyxin b sulfateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Polymyxin B Sulfate
Manufacturer
Xellia Pharmaceuticals USA LLC
Country
United States (US)
ATC code
J01XB02
ATC class
Polymyxin B
Defined daily dose
0.15 g, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 2

  • ndc11
    7059404901
    1 VIAL, GLASS in 1 CARTON (70594-049-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    7059404902
    10 VIAL, GLASS in 1 CARTON (70594-049-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Regulatory notes

UNII (FDA substance ID)
19371312D4
POLYMYXIN B SULFATE
RxCUI 388
Orange Book
A202766
AP
DailyMed SPL labels
1 version tracked

Interactions

76 interactions on record for polymyxin b.

Graded by severity as the source publishes them — 44 severe. 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
Check polymyxin b against other medicinesHow interaction checks work

Polymyxin b · interactions on record

76 records

  • 44 severe
  • 31 moderate
  • 1 minor

Most severe, free to view

  • NeomycinA07AA01severe
  • StreptomycinA07AA04severe
  • KanamycinA07AA08severe
  • NeomycinB05CA09severe
  • 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

Polymyxin b 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 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/ce2450af-c672-46d9-8aec-3fa60b517caf
GET /v1/drugs/ce2450af-c672-46d9-8aec-3fa60b517caf?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.

{
  "unii": {
    "unii": "19371312D4",
    "rxcui": "388",
    "inchikey": null,
    "display_name": "POLYMYXIN B SULFATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC",
  "spl_meta": {
    "31a7ad1f-3f58-41a0-94f0-36674285bb61": {
      "match": "brand_token",
      "title": "POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2026-03-04"
    }
  },
  "productid": "70594-049_fda91987-b6cd-4233-b09c-0f0300ad5df2",
  "productndc": "70594-049",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202766",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500,000 UNITS BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 15, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYMYXIN B SULFATE",
  "proprietary_name": "Polymyxin B",
  "active_ingred_unit": "[USP'U]/1",
  "application_number": "ANDA202766",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polymyxin B Sulfate",
  "start_marketing_date": "20181001",
  "active_numerator_strength": "500000"
}
API referenceMCP serverPlans

See everything about polymyxin b.

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.

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