Medicine
Timolol 5 mg/mL ophthalmic solution
Timolol 5 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 6 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
Protect from freezing. Store at room temperature 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Timolol
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle, 5 mL, 10 mL and 12 more
- Manufacturers
- Caplin SterilesIndiaAurobindo PharmaIndiaBausch & Lomb AmericasLeading PharmaSandozA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at room temperature 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C07AA06 Timolol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 January 1996
- Identifiers
- RxCUI 1923428, 1992303, 313408 +1DailyMed set ID f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea, 4847f180-45e6-40f0-ae8c-6cc500cb0add, 9c14ca2d-80f3-48ef-b99a-beafaa728a24 +5NDC 61314-227, 65145-152, 82260-813 +7Application ANDA074262, ANDA218460, NDA018086 +2
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 in 1 carton / 5 mL in 1 bottle | 65145-152-01 | Caplin SterilesIndia | 16 September 2024 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 65145-153-01 | Caplin SterilesIndia | 16 September 2024 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 65145-154-01 | Caplin SterilesIndia | 16 September 2024 |
| 1 bottle, dispensing in 1 carton / 5 mL in 1 bottle, dispensing | 59651-313-05 | Aurobindo PharmaIndia | 23 March 2023 |
| 1 bottle, dispensing in 1 carton / 5 mL in 1 bottle, dispensing | 82260-813-05 | Bausch & Lomb Americas | 1 June 2020 |
| 1 bottle, dispensing in 1 carton / 10 mL in 1 bottle, dispensing | 82260-813-10 | Bausch & Lomb Americas | 1 June 2020 |
| 1 bottle, dispensing in 1 carton / 5 mL in 1 bottle, dispensing | 82260-819-05 | Bausch & Lomb Americas | 14 February 2018 |
| 5 mL in 1 bottle, plastic | 69315-325-05 | Leading Pharma | 7 November 2024 |
| 10 mL in 1 bottle, plastic | 69315-325-10 | Leading Pharma | 7 November 2024 |
| 15 mL in 1 bottle, plastic | 69315-325-15 | Leading Pharma | 7 November 2024 |
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 61314-227-05 | Sandoz | 15 January 1996 |
| 1 bottle, plastic in 1 carton / 10 mL in 1 bottle, plastic | 61314-227-10 | Sandoz | 15 January 1996 |
| 1 bottle, plastic in 1 carton / 15 mL in 1 bottle, plastic | 61314-227-15 | Sandoz | 15 January 1996 |
| 10 mL in 1 bottle, plastic | 50090-3441-0 | A-S Medication Solutions | 20 April 2018 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 50090-7837-0 | A-S Medication Solutions | 29 December 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 17 August 1978 | 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
Alternatives
Other makers and brands of Timolol 5 mg/mL ophthalmic solution.
Other strengths and forms of Timolol
Clinical summary
Timolol is a beta-adrenergic blocker indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It is available as eye drops, ophthalmic solution and gel-forming eye drops for oral use. MedsAcross supplies 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 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
- Timolol Maleate prescribing information (Bausch & Lomb Americas) · U.S. National Library of Medicine, DailyMed
Need Timolol 5 mg/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.