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MedsAcross

Medicine

Timolol 6.8 mg/mL eye drops

Timolol · Ophthalmic
Available on requestPrescription onlyUS FDAGeneric name

Timolol 6.8 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 2 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

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
6.8 mg/mL
Dosage form
Eye drops
Route
Ophthalmic
Packs
6 pouches, 15 pouches
Manufacturers
Micro LabsIndiaIngenus Pharmaceuticals
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 September 2022
Identifiers
RxCUI 1922876, 1922894DailyMed set ID 4c4318b3-9865-4172-a7bd-9e68913eca1e, 79b223e4-d929-4667-8149-e79bfab13fdfNDC 50742-288, 42571-398Application ANDA216533, ANDA216596

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
6 pouch in 1 carton / 10 vial in 1 pouch / .3 mL in 1 vial42571-398-71Micro LabsIndia1 January 2023
15 pouch in 1 carton / 4 container in 1 pouch / .3 mL in 1 container50742-288-60Ingenus Pharmaceuticals15 September 2022

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 17 August 1978Drugs@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

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 Timolol

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

Data sources

Need Timolol 6.8 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.