Medicine
Betoptic S 2.8 mg/mL ophthalmic suspension
Betoptic S 2.8 mg/mL ophthalmic suspension is a prescription medicine containing Betaxolol for ophthalmic use, marketed by Novartis Pharmaceuticals, 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 upright at 2°C to 25°C (36°F to 77°F).
Key facts
- Active ingredient (INN)
- Betaxolol
- Brand
- Betoptic S
- Strength
- 2.8 mg/mL
- Dosage form
- Ophthalmic suspension
- Route
- Ophthalmic
- Packs
- 1 bottle
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store upright at 2°C to 25°C (36°F 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 January 1996
- Identifiers
- RxCUI 213729, 308719DailyMed set ID 905ba189-456c-4aa4-8231-39a971374ad8NDC 0078-0729Application NDA019845
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 10 mL in 1 bottle | 0078-0729-10 | Novartis Pharmaceuticals | 3 August 2022 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 0078-0729-15 | Novartis Pharmaceuticals | 3 August 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 August 1985 | 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 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 BetaxololFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Betaxolol Hydrochloride prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Betoptic S 2.8 mg/mL ophthalmic suspension 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.