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United States· US:68788-4084_95d70587-2cf2-4e14-8ca3-11b762f1188b

Ketotifen Fumarate Ophthalmic Solution

A ketotifen product containing ketotifen fumarate, registered in United States by Preferred Pharmaceuticals Inc.. The same ATC class is registered in 13 of our 19 countries.

ATC S01GX08US 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…normalisedKetotifen Fumarate Ophthalmic SolutionATCS01GX08REGISTER NO.US:68788-4084_95d7058…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ketotifen fumarateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ketotifen is registered in 13 of 19 countries.

Countries holding a registration under ATC S01GX08 (ketotifen), each read from that country’s own register.

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

Ketotifen · ATC S01GX08

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • 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
KETOTIFEN FUMARATE
Manufacturer
Preferred Pharmaceuticals Inc.
Country
United States (US)
ATC code
S01GX08
ATC class
Ketotifen
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    6878840845
    1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    68788-4084-5

Regulatory notes

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

Same medicine, other countries

Ketotifen in 16 other countries

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

All ketotifen products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Ketotifen Stulln, Ketotifen Stulln 0,25 Mg/Ml Augentropfen Pharma Stulln
  • Belgium · Altriabak, Ketazed
  • Bulgaria · Ketotifen Sopharma, Забак
  • Cyprus · Meni-Drops, Tenerel
  • Czechia · Ketof, Ketotifen Al
  • Germany · Allergo-Vision Sine, Ketazed
  • Denmark · Ketazed, Zaditen
  • Spain · Bentifen, Ketisal
  • Finland · Ketazed, Ketotifen Stulln 0,25 Mg/Ml Silmätipat, Liuos
  • France · Ketazed, Monoketo
  • United Kingdom (Northern Ireland) · Ketazed, Ketofall
  • Greece · Cleroptic, K-Drops
  • Ireland · Ketofall, Zaditen
  • Iceland · Zaditen
  • Italy · Brunistill, Chetotifene Mylan Generics
  • Luxembourg · Altriabak, Ketazed
  • Latvia · Ketotifen
  • Netherlands · Altriabak, Ketazed
  • Norway · Ketazed, Zaditen
  • Poland · Ketotifen Hasco, Ketotifen Stulln
  • Portugal · Lidina, Lidinafree
  • Romania · Ketazed, Ketof
  • Sweden · Bentifen, Ketazed
  • Slovenia · Zaditen, Zaditen Sdu
  • Slovakia · Denerel, Zaditen

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/df335dfd-c5b3-4ff7-aab0-4d5e379f5703
GET /v1/drugs/df335dfd-c5b3-4ff7-aab0-4d5e379f5703?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": ".25",
  "substance": "KETOTIFEN FUMARATE",
  "productndc": "68788-4084",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA077958",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about ketotifen.

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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