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MedsAcross

Medicine

Betaxolol 5.6 mg/mL eye drops

Betaxolol · Ophthalmic
Available on requestPrescription onlyUS FDAGeneric name

Betaxolol 5.6 mg/mL eye drops is a generic prescription medicine for ophthalmic use, 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

Store at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Betaxolol
Brand
Sold under the generic name
Strength
5.6 mg/mL
Dosage form
Eye drops
Route
Ophthalmic
Packs
1 bottle
Manufacturer
Sandoz
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C07AB05 Betaxolol
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 May 2000
Identifiers
RxCUI 308720DailyMed set ID a73519d5-546c-4377-92ed-0d4be2685d60NDC 61314-245Application NDA019270

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

PackCodeLabelerMarketed since
1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic61314-245-01Sandoz15 May 2000
1 bottle, plastic in 1 carton / 15 mL in 1 bottle, plastic61314-245-02Sandoz15 May 2000
1 bottle, plastic in 1 carton / 10 mL in 1 bottle, plastic61314-245-03Sandoz15 May 2000

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 30 August 1985Drugs@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 Betaxolol

Clinical summary

Betaxolol is a beta-adrenergic blocker indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It is available as tablets, eye drops and ophthalmic suspension for oral use. MedsAcross supplies Betaxolol 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 Betaxolol

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

Data sources

Need Betaxolol 5.6 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.