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United States· US:82584-604_51b818ee-6194-a845-e063-6394a90ae44b

COSOPT PF

A medicinal product containing dorzolamide hydrochloride; timolol maleate, registered in United States by Thea Pharma Inc..

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…normalisedCOSOPT PFATC—REGISTER NO.US:82584-604_51b818ee…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dorzolamide hydrochloride; timolol maleateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Manufacturer
Thea Pharma Inc.
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
    8258460430
    4 POUCH in 1 CARTON (82584-604-30) / 15 VIAL, SINGLE-DOSE in 1 POUCH (82584-604-01) / .2 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    82584-604-30

Regulatory notes

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

Same medicine, other countries

Dorzolamide hydrochloride; timolol maleate in 15 other countries

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

All dorzolamide hydrochloride; timolol maleate products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Cosopt, Cosopt Sine
  • Belgium · Cosopt, Cosopt Sine Conservans
  • Bulgaria · Амиптифри, Дорзасопт
  • Cyprus · Cosopt, Cosopt Imulti
  • Czechia · Amiptic, Cosopt
  • Germany · Cosduo, Cosopt
  • Denmark · Cosopt, Cosopt Imulti Ukonserveret
  • Estonia · Cosopt, Dorzolamide/Timolol Elvim
  • Spain · Arzotim, Cosduo
  • Finland · Cosopt, Cosopt Sine
  • France · Atimiac, Cosidime
  • United Kingdom (Northern Ireland) · Codimaz, Cosopt
  • Greece · Apleona, Cosopt
  • Croatia · Apleona, Cosopt
  • Hungary · Cosopt, Cosopt Multi
  • Ireland · Cosopt, Cosopt Preservative-Free
  • Iceland · Arzotilol, Cosopt Sine
  • Italy · Betaclar, Cosopt
  • Lithuania · Cosopt, Cosopt Sine
  • Luxembourg · Cosopt, Cosopt Sine Conservans
  • Latvia · Amiptic, Amiptinon
  • Malta · Cosopt Preservative-Free
  • Netherlands · Cosopt, Cosopt Conserveermiddelvrij, Oogdruppels, Oplossing, Flacon Voor Eenmalig Gebruik
  • Norway · Apleona, Cosopt
  • Poland · Cosopt, Cosopt Pf
  • Portugal · Cosopt, Cosopt Multi
  • Romania · Cosopt, Cosopt Fără Conservant
  • Sweden · Cosopt, Cosopt Sine
  • Slovenia · Cosopt, Cosopt Brez Konzervansa
  • Slovakia · Cosopt, Cosopt Free

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/ebcd5d4f-0952-4426-97e7-5cf0de1ffa24
GET /v1/drugs/ebcd5d4f-0952-4426-97e7-5cf0de1ffa24?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": "20; 5",
  "substance": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
  "productndc": "82584-604",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL; mg/mL",
  "application_number": "NDA202667",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about dorzolamide hydrochloride; timolol maleate.

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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