Medicine
Dorzolamide and Timolol 20 mg/5 mg per mL eye drops
Dorzolamide and Timolol 20 mg/5 mg per mL eye drops is a generic prescription medicine for ophthalmic use, made by 10 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°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Dorzolamide and Timolol
- Brand
- Sold under the generic name
- Strength
- 20 mg/5 mg per mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle, 12 pouches, 4 pouches and 12 more
- Manufacturers
- Aurobindo PharmaIndiaAlembic PharmaceuticalsIndiaMicro LabsIndiaGland PharmaIndiaBausch & LombBryant Ranch PrepackA-S Medication SolutionsFlorida Pharmaceutical ProductsIngenus Pharmaceuticals10 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F 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
- 14 July 2009
- Identifiers
- RxCUI 1923432, 1922783DailyMed set ID ff76c0cf-256c-4015-94f4-405f0c46205f, 8cdf22c8-75ca-404e-b354-9e254690d0e7, 6b9c446e-7068-479b-8611-aead7a8d2f50 +10NDC 72162-2166, 50090-6371, 62332-553 +10Application ANDA090037, ANDA213099, ANDA207629 +6
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 / 10 mL in 1 bottle | 46708-553-10 | Alembic PharmaceuticalsIndia | 4 May 2021 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 62332-553-10 | Alembic PharmaceuticalsIndia | 4 May 2021 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 65862-946-01 | Aurobindo PharmaIndia | 14 May 2021 |
| 12 pouch in 1 carton / 15 vial, single-use in 1 pouch / .2 mL in 1 vial, single-use | 65862-947-18 | Aurobindo PharmaIndia | 24 July 2018 |
| 4 pouch in 1 carton / 15 vial, single-use in 1 pouch / .2 mL in 1 vial, single-use | 65862-947-60 | Aurobindo PharmaIndia | 24 July 2018 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 68083-490-01 | Gland PharmaIndia | 19 September 2022 |
| 12 pouch in 1 carton / 15 vial, single-use in 1 pouch / .2 mL in 1 vial, single-use | 42571-382-27 | Micro LabsIndia | 23 March 2022 |
| 4 pouch in 1 carton / 15 vial, single-use in 1 pouch / .2 mL in 1 vial, single-use | 42571-382-73 | Micro LabsIndia | 23 March 2022 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 24208-486-05 | Bausch & Lomb | 14 July 2009 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-486-10 | Bausch & Lomb | 14 July 2009 |
| 1 bottle, dispensing in 1 carton / 10 mL in 1 bottle, dispensing | 71921-226-10 | Florida Pharmaceutical Products | 16 August 2023 |
| 12 pouch in 1 carton / 5 vial in 1 pouch / .2 mL in 1 vial | 50742-323-60 | Ingenus Pharmaceuticals | 2 May 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 72162-2166-2 | Bryant Ranch Prepack | 7 December 2023 |
| 4 pouch in 1 carton / 15 vial, single-use in 1 pouch / .2 mL in 1 vial, single-use | 72162-2387-6 | Bryant Ranch Prepack | 20 August 2024 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 50090-6371-0 | A-S Medication Solutions | 13 February 2023 |
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 7 April 1998 | 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 Dorzolamide and Timolol 20 mg/5 mg per mL eye drops.
Other strengths and forms of Dorzolamide and Timolol
Clinical summary
Dorzolamide and Timolol is a fixed-dose combination of a carbonic anhydrase inhibitor and a beta-adrenergic blocker indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. MedsAcross supplies Dorzolamide 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 Dorzolamide 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
- COSOPT prescribing information (Thea Pharma) · U.S. National Library of Medicine, DailyMed
Need Dorzolamide and Timolol 20 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.