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Medicine

Brimonidine and Timolol 2 mg/5 mg per mL eye drops

Available on requestPrescription onlyUS FDAGeneric name

Brimonidine and Timolol 2 mg/5 mg per mL eye drops is a generic prescription medicine for ophthalmic use, made by 9 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 15° to 25°C (59° to 77°F). Protect from light.

Key facts

Active ingredient (INN)
Brimonidine and Timolol
Brand
Sold under the generic name
Strength
2 mg/5 mg per mL
Dosage form
Eye drops
Route
Ophthalmic
Packs
1 bottle and 24 more
Manufacturers
Alembic PharmaceuticalsIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaNorthStar RxLLCSandozSomerset TherapeuticsUpsher-Smith LaboratoriesArmas PharmaceuticalsDevatis
Origin register
US FDA, United States
Storage
Store at 15° to 25°C (59° to 77°F). Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
13 April 2022
Identifiers
RxCUI 861635DailyMed set ID af21d2e5-0029-4889-ba93-6417baa91ce6, b5d560b6-847e-4f09-b1ef-22e4deb8a206, e4fdbd17-73b7-49ed-9de3-591f36e0645d +7NDC 0781-7186, 46708-706, 70069-651 +11Application ANDA091087, ANDA215230, ANDA216114 +5

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper68083-624-01Gland PharmaIndia11 June 2026
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper68083-625-01Gland PharmaIndia11 June 2026
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper68083-664-01Gland PharmaIndia11 June 2026
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper46708-706-05Alembic PharmaceuticalsIndia25 August 2023
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper46708-706-10Alembic PharmaceuticalsIndia25 August 2023
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper46708-706-15Alembic PharmaceuticalsIndia25 August 2023
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper62332-706-05Alembic PharmaceuticalsIndia25 August 2023
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper62332-706-10Alembic PharmaceuticalsIndia25 August 2023
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper62332-706-15Alembic PharmaceuticalsIndia25 August 2023
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper68462-281-32Glenmark PharmaceuticalsIndia16 May 2024
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper68462-281-69Glenmark PharmaceuticalsIndia16 May 2024
1 bottle in 1 carton / 5 mL in 1 bottle70069-651-01Somerset Therapeutics10 October 2024
1 bottle in 1 carton / 10 mL in 1 bottle70069-652-01Somerset Therapeutics10 October 2024
1 bottle in 1 carton / 15 mL in 1 bottle70069-653-01Somerset Therapeutics10 October 2024
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper72485-634-05Armas Pharmaceuticals3 November 2023
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper72485-634-10Armas Pharmaceuticals3 November 2023
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper73043-029-01Devatis15 September 2026
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper73043-029-02Devatis15 September 2026
1 bottle in 1 carton / 10 mL in 1 bottle0781-7186-70Sandoz13 April 2022
1 bottle in 1 carton / 5 mL in 1 bottle0781-7186-75Sandoz13 April 2022
1 bottle in 1 carton / 15 mL in 1 bottle0781-7186-85Sandoz13 April 2022
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper0832-1425-05Upsher-Smith Laboratories9 January 2023
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper0832-1425-10Upsher-Smith Laboratories9 January 2023
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper0832-1425-15Upsher-Smith Laboratories20 October 2023
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper72603-931-05NorthStar RxLLC24 April 2026
1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper72603-931-10NorthStar RxLLC24 April 2026
1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper72603-931-15NorthStar RxLLC28 September 2026

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 October 2007Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Brimonidine and Timolol 2 mg/5 mg per mL eye drops.

Compare 1

Other strengths and forms of Brimonidine and Timolol

Clinical summary

Brimonidine and Timolol is a fixed-dose combination of an alpha-adrenergic agonist and a beta-adrenergic blocker indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, among other approved uses. MedsAcross supplies Brimonidine and Timolol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Brimonidine and Timolol

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Brimonidine and Timolol 2 mg/5 mg per mL eye drops for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.