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United States· US:75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5

OFLOXACIN

A ofloxacin product containing ofloxacin, registered in United States by Nivagen Pharmaceuticals, Inc.. The same ATC class is registered in 10 of our 19 countries.

ATC J01MA01US 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…normalisedOFLOXACINATCJ01MA01REGISTER NO.US:75834-112_67a823b3…PACKS LISTED6CHECKEDAugust 23, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ofloxacinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ofloxacin is registered in 10 of 19 countries.

Countries holding a registration under ATC J01MA01 (ofloxacin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose
Search ofloxacin products by name

Ofloxacin · ATC J01MA01

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Germany
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
OFLOXACIN
Manufacturer
Nivagen Pharmaceuticals, Inc.
Country
United States (US)
ATC code
J01MA01
ATC class
Ofloxacin
Defined daily dose
0.4 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 23, 2026

Packs & prices · 6

  • ndc11
    7583411201
    100 TABLET, COATED in 1 BOTTLE (75834-112-01)
  • ndc11
    7583411205
    500 TABLET, COATED in 1 BOTTLE (75834-112-05)
  • ndc11
    7583411250
    50 TABLET, COATED in 1 BOTTLE (75834-112-50)
  • ndc11
    75834-112-01
  • ndc11
    75834-112-05
  • ndc11
    75834-112-50

Regulatory notes

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

Interactions

596 interactions on record for ofloxacin.

Graded by severity as the source publishes them — 86 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 ofloxacin against other medicinesHow interaction checks work

Ofloxacin · interactions on record

596 records

  • 86 severe
  • 216 moderate
  • 51 minor
  • 170 info

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • DolasetronA04AA04severe
  • PrednisoloneA07EA01severe

73 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Ofloxacin in 15 other countries

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

All ofloxacin products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Floxal, Floxal Edo
  • Belgium · Trafloxal, Trafloxal Edo
  • Bulgaria · Медофлоксин, Офлоксацин Дра
  • Cyprus · Cilox, Medofloxine
  • Czechia · Floxal, Ofloxacin Unimed Pharma
  • Germany · Floxal, Floxal Edo
  • Estonia · Medofloxine, Ofloxin
  • Spain · Exocin, Oflovir
  • Finland · Exocin
  • France · Exocine, Monoflocet
  • United Kingdom (Northern Ireland) · Exocin, Ofloxacin Bristol Laboratories
  • Greece · Exocin, Oxatrex
  • Croatia · Uniflox
  • Hungary · Floxal, Grenis-Oflo
  • Ireland · Exocin
  • Italy · Dunaflot, Exocin
  • Lithuania · Ofloxin, Uniflox
  • Luxembourg · Ofloxa-Vision Kombi-Packung, Visioflox
  • Latvia · Ofloxin, Uniflox
  • Malta · Uniflox Unimed Pharma
  • Netherlands · Ofloxacine 200 Pch, Ofloxacine 400 Pch
  • Poland · Floxal, Oflodinex
  • Portugal · Audret, Bioquil
  • Romania · Floxal, Ofloxacină Laropharm
  • Sweden · Ofloxacin Mibe
  • Slovakia · Medofloxine, Ofloxin

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/b375ddfc-2415-4f43-a8a7-51a095737c8c
GET /v1/drugs/b375ddfc-2415-4f43-a8a7-51a095737c8c?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": "ORAL",
  "source": "ndc",
  "strength": "400",
  "substance": "OFLOXACIN",
  "productndc": "75834-112",
  "dosage_form": "TABLET, COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA091656",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about ofloxacin.

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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