Medicine
Dorzolamide 20 mg/mL eye drops
Dorzolamide 20 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 8 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 dorzolamide hydrochloride ophthalmic solution at 20° to 25°C (68° to…
Key facts
- Active ingredient (INN)
- Dorzolamide
- Brand
- Sold under the generic name
- Strength
- 20 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle and 7 more
- Manufacturers
- Alembic PharmaceuticalsIndiaIndoco RemediesIndiaMicro LabsIndiaA-S Medication SolutionsBausch & LombSagent PharmaceuticalsSandozSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store dorzolamide hydrochloride ophthalmic solution at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- S01EC03 Dorzolamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2009
- Identifiers
- RxCUI 310015DailyMed set ID 91df460c-b896-4600-9d33-e499b49ba1b6, 462a61b2-1ec6-4d18-bc6b-fc03e027caa0, fa4b8802-3271-48a4-8a91-229ebc72f570 +7NDC 50090-2406, 14445-404, 50090-4882 +7Application ANDA090143, ANDA202053, ANDA204778 +4
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 | 46708-519-10 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 62332-519-10 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 1 bottle, dispensing in 1 carton / 10 mL in 1 bottle, dispensing | 14445-404-10 | Indoco RemediesIndia | 14 May 2021 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 42571-141-26 | Micro LabsIndia | 11 November 2019 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-485-10 | Bausch & Lomb | 25 June 2009 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 25021-006-10 | Sagent Pharmaceuticals | 15 January 2026 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 61314-019-10 | Sandoz | 1 June 2009 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 70069-501-01 | Somerset Therapeutics | 12 February 2025 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 50090-2406-0 | A-S Medication Solutions | 18 May 2016 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 50090-4882-0 | A-S Medication Solutions | 11 February 2020 |
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 9 December 1994 | 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 Dorzolamide
Clinical summary
Dorzolamide is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It is available as eye drops and ophthalmic solution. MedsAcross supplies Dorzolamide 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 DorzolamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dorzolamide HCl prescribing information (Bausch & Lomb) · U.S. National Library of Medicine, DailyMed
Need Dorzolamide 20 mg/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.