United States· US:54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1

Levofloxacin

A medicinal product containing levofloxacin, registered in United States by BPI LABS 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…normalisedLevofloxacinATC—REGISTER NO.US:54288-140_4c9a6374…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
LEVOFLOXACIN
Manufacturer
BPI LABS 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
    5428814001
    1 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON
  • ndc11
    54288-140-01

Regulatory notes

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

Same medicine, other countries

Levofloxacin in 16 other countries

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

All levofloxacin products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Levofloxacin 1a Pharma, Levofloxacin Actavis
  • Belgium · Levofloxacin Noridem, Levofloxacine Eg
  • Bulgaria · Levofloxacin Kabi, Levor 5 Mg/Ml
  • Cyprus · Amesol, Fairlim
  • Czechia · Levofloxacin Aptapharma, Levofloxacin Kabi
  • Germany · Levoflox, Levofloxacin 1 A Pharma
  • Denmark · Levofloxacin Macure, Levofloxacin Noridem
  • Estonia · Levnibiot, Levofloxacin Basi
  • Spain · Bactyflox, Levofloxacin Sanovel
  • Finland · Levofloxacin Fresenius Kabi, Levofloxacin Krka
  • France · Levofloxacine Accord Healthcare, Levofloxacine Almus
  • United Kingdom (Northern Ireland) · Evoxil, Eyflox
  • Greece · Cinlevo, Evoxil
  • Croatia · Flexid, Fovelid
  • Hungary · Avatac, Leflokin
  • Ireland · Levofloxacin, Levofloxacin Hikma Farmaceutica
  • Iceland · Oftaquix, Quinsair
  • Italy · Agilev, Allgram
  • Liechtenstein · Quinsair
  • Lithuania · Levalox, Levofloxacin Actavis
  • Luxembourg · Levofloxacine Eg, Levofloxacine Fresenius Kabi
  • Latvia · Levalox, Levofloxacin Basi
  • Malta · Evoxil, Floxaval
  • Netherlands · Levofloxacin Hemihydrate Aurobindo, Levofloxacine Beximco
  • Norway · Levofloxacin Macure, Levofloxacin Noridem Enterprises
  • Poland · Levalox, Levocin
  • Portugal · Lenovan, Levofloxacina
  • Romania · Cenomar, Fleraday
  • Sweden · Levofloxacin Actavis, Levofloxacin Krka
  • Slovenia · Leviaben, Levofloksacin Aptapharma
  • Slovakia · Levalox, Levofloxacin Aptapharma

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/ce22a1c5-2702-441b-aa47-297600730be2
GET /v1/drugs/ce22a1c5-2702-441b-aa47-297600730be2?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": "OPHTHALMIC",
  "source": "ndc",
  "strength": "15",
  "substance": "LEVOFLOXACIN",
  "productndc": "54288-140",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA205600",
  "marketing_category": "ANDA"
}

See everything about levofloxacin.

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.