Medicine
Brimonidine and Timolol 2 mg/5 mg per mL ophthalmic solution
Brimonidine and Timolol 2 mg/5 mg per mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 4 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° -25°C (68° -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
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle and 9 more
- Manufacturers
- Caplin SterilesIndiaApotexFlorida Pharmaceutical ProductsLeading Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° -25°C (68° -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
- 19 October 2022
- Identifiers
- RxCUI 861635DailyMed set ID eac3cec2-b373-4936-89f0-c6d300e09f6e, 533f9979-0cd7-485c-8c50-abbf717c5031, 268c3f6b-8798-7987-3b8c-7b7f560af5d7 +1NDC 65145-164, 69315-330, 60505-0589 +3Application ANDA219093, ANDA091442, ANDA201949
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 65145-162-01 | Caplin SterilesIndia | 10 March 2025 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 65145-163-01 | Caplin SterilesIndia | 10 March 2025 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 65145-164-01 | Caplin SterilesIndia | 10 March 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 60505-0589-1 | Apotex | 19 October 2022 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 60505-0589-2 | Apotex | 19 October 2022 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 60505-0589-3 | Apotex | 19 October 2022 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 71921-188-05 | Florida Pharmaceutical Products | 23 November 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 71921-188-10 | Florida Pharmaceutical Products | 23 November 2023 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 71921-188-15 | Florida Pharmaceutical Products | 23 November 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 69315-330-05 | Leading Pharma | 29 May 2025 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 69315-330-10 | Leading Pharma | 29 May 2025 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 69315-330-15 | Leading Pharma | 29 May 2025 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 October 2007 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
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 TimololFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- COMBIGAN prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Brimonidine and Timolol 2 mg/5 mg per mL ophthalmic solution 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.