United States· US:68083-625_8c333ddc-18f1-4afc-8a70-1641c4f21ceb

Brimonidine Tartrate and Timolol maleate Ophthalmic Solution

A medicinal product containing brimonidine tartrate; timolol maleate, registered in United States by Gland Pharma Limited.

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Manufacturer: Gland 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: September 27, 2026

Packs & prices · 1

ndc11
68083-625-01

Regulatory notes

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

Same medicine, other countries

Brimonidine tartrate; timolol maleate in 13 other countries

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

All brimonidine tartrate; timolol maleate products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

Austria · Bazofex, Brimosine Duo
Belgium · Combigan
Bulgaria · Brimosine Duo, Бримонидин/Тимолол Ромфарм
Cyprus · Brimonidine Tartrate / Timolol Kleva
Czechia · Brimonidin/Timolol Olikla, Combigan
Germany · Brimonidin/Timolol Pharmathen, Brimosine Duo
Denmark · Brimonidin/Timolol Stada, Brimonidintartrat/Timolol Doc Generici
Estonia · Combigan
Spain · Combigan, Duabrima
Finland · Combigan
France · Brimonidine /Timolol Viatris, Brimonidine/Timolol Biogaran
United Kingdom (Northern Ireland) · Abrivis Duo, Brimonidine Tartrate /Timolol Generics [uk]
Greece · Brimontal-Co, Combigan
Croatia · Bericomb, Combigan
Hungary · Combigan
Ireland · Combigan
Italy · Brimocomb, Brimonidina E Timololo Mylan
Lithuania · Combigan
Luxembourg · Combigan
Latvia · Combigan
Netherlands · Brimonidinetartraat/Timolol Blumont, Combigan
Norway · Combigan
Poland · Combigan
Portugal · Bericomb, Bglau Duo
Romania · Briminodină/Timolol Rompharm, Combigan
Sweden · Combigan
Slovenia · Combigan
Slovakia · Bericomb, Brimonidin/Timolol Olikla

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/f87b3358-962b-46f9-ab02-52b361e16bca
GET /v1/drugs/f87b3358-962b-46f9-ab02-52b361e16bca?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": "2; 5",
  "substance": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
  "productndc": "68083-625",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL; mg/mL",
  "application_number": "ANDA219166",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

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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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