United States· US:65862-946_ce99a7ff-3420-478f-90b8-cde6238f158a
Dorzolamide Hydrochloride and Timolol Maleate
A medicinal product containing dorzolamide hydrochloride; timolol maleate, registered in United States by Aurobindo Pharma Limited.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Manufacturer
- Aurobindo Pharma Limited
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 9, 2026
Packs & prices · 2
- ndc1165862946011 BOTTLE, DROPPER in 1 CARTON (65862-946-01) / 10 mL in 1 BOTTLE, DROPPER
- ndc1165862-946-01
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.
- PolandCosopt PFSanten Oy
- United KingdomCodimaz 20mg/ml / 5mg/ml eye dropsScope Ophthalmics Ltd
- CzechiaAMIPTICZaklady Farmaceutyczne Polpharma SA, Starogard Gdański
- GermanyCosduoSanten Oy
- SwedenCosopt 20 mg/ml + 5 mg/ml Ögondroppar, lösningSanten Oy
- SpainARZOTIM 20 MG/ML + 5 MG/ML COLIRIO EN SOLUCIONTiedra Farmaceutica S.L.
- FinlandCosoptSanten Oy
- ItalyBETACLAROMNIVISION ITALIA S.R.L.
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/bece4f7e-e770-4ecd-b920-28e45ed1b392 GET /v1/drugs/bece4f7e-e770-4ecd-b920-28e45ed1b392?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": "65862-946",
"dosage_form": "SOLUTION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL; mg/mL",
"application_number": "ANDA207629",
"marketing_category": "ANDA"
}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.