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United States· US:63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f

Imipenem and Cilastatin

A imipenem and cilastatin product containing imipenem; cilastatin sodium, registered in United States by Fresenius Kabi USA, LLC. The same ATC class is registered in 12 of our 19 countries.

ATC J01DH51US 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…normalisedImipenem and CilastatinATCJ01DH51REGISTER NO.US:63323-349_2bb9b6ad…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Imipenem and cilastatin is registered in 12 of 19 countries.

Countries holding a registration under ATC J01DH51 (imipenem and cilastatin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 7 of them publish a price we can compare per daily dose

Imipenem and cilastatin · ATC J01DH51

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
IMIPENEM; CILASTATIN SODIUM
Manufacturer
Fresenius Kabi USA, LLC
Country
United States (US)
ATC code
J01DH51
ATC class
Imipenem and cilastatin
Defined daily dose
2 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
    63323-349-25
  • ndc11
    6332334925
    25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01)

Regulatory notes

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

Interactions

1 interaction on record for imipenem and cilastatin.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Imipenem and cilastatin · interactions on record

1 record

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Imipenem and cilastatin in 11 other countries

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

All imipenem and cilastatin products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Imipenem/Cilastatin Aptapharma, Imipenem/Cilastatin Eberth
  • Bulgaria · Имипенем/Циластатин Аптафарма, Мирон
  • Cyprus · Imicilast, Imipenem + Cilastatina Venus Pharma
  • Czechia · Enaros, Imipenem/Cilastatin Aptapharma
  • Germany · Imipenem Cilastatin Panpharma, Imipenem/Cilastatin Basics
  • Denmark · Andatin, Imipenem/Cilastatin Noridem
  • Estonia · Imipenem/Cilastatin Kabi
  • Spain · Enaros, Imipenem/Cilastatina Aurovitas
  • Finland · Andatin, Imipenem/Cilastatin Noridem
  • France · Imipenem Cilastatine Panpharma, Imipenem Cilastatine Sun
  • United Kingdom (Northern Ireland) · Imipenem/Cilastatin Accord Healthcare, Imipenem/Cilastatin Fresenius Kabi
  • Greece · Imicil, Imipenem+cilastatin /Kabi
  • Croatia · Imipenem/Cilastatin Aptapharma, Imipenem/Cilastatin Kabi
  • Hungary · Imipenem/Cilastatin Aptapharma, Imipenem/Cilastatin Kabi
  • Ireland · Imipenem/Cilastatin, Imipenem/Cilastatin Hikma Farmacêutica Portugal
  • Italy · Imipenem E Cilastatina Aurobindo, Imipenem E Cilastatina Hikma Farmacêutica
  • Lithuania · Imipenem/Cilastatin Sun, Stinem
  • Latvia · Imipenem/Cilastatin Sun
  • Malta · Imipenem/Cilastatin Aptapharma, Miron
  • Netherlands · Imipenem/Cilastatine Fresenius Kabi, Imipenem/Cilastatine Hikma
  • Norway · Andatin, Imipenem/Cilastatin Fresenius Kabi
  • Poland · Imipenem + Cilastatin Aptapharma, Imipenem + Cilastatin Noridem
  • Portugal · Enaros, Imipenem + Cilastatina Aurovitas
  • Romania · Cilopen, Imipenem/Cilastatin Aptapharma
  • Sweden · Imipenem/Cilastatin Fresenius Kabi, Imipenem/Cilastatin Noridem
  • Slovenia · Imipenem/Cilastatin Aptapharma, Imipenem/Cilastatin Kabi
  • Slovakia · Imipenem/Cilastatin Aptapharma, Imipenem/Cilastatin 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/ace1bf34-1119-47b0-b727-ac4e2c930246
GET /v1/drugs/ace1bf34-1119-47b0-b727-ac4e2c930246?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "250; 250",
  "substance": "IMIPENEM; CILASTATIN SODIUM",
  "productndc": "63323-349",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/20mL; mg/20mL",
  "application_number": "ANDA090577",
  "marketing_category": "ANDA"
}

See everything about imipenem and cilastatin.

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.