Medicine
Bepotastine 15 mg/mL eye drops
Bepotastine 15 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 4 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 15°C to 25°C (59°F to 77°F).
Key facts
- Active ingredient (INN)
- Bepotastine
- Brand
- Sold under the generic name
- Strength
- 15 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle and 7 more
- Manufacturers
- Alembic PharmaceuticalsIndiaBausch & LombBausch & Lomb AmericasMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 15°C to 25°C (59°F to 77°F).
- 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
- 28 May 2021
- Identifiers
- RxCUI 863038DailyMed set ID de111d74-c740-47b3-adc7-4b855df2c561, 995f4fe0-d861-4137-8090-a8ffc71c46f4, 75178670-aa57-45f9-94d5-efcf8305e683 +2NDC 46708-598, 24208-630, 0378-7055 +2Application ANDA214588, NDA022288, ANDA206220
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 / 5 mL in 1 bottle | 46708-598-05 | Alembic PharmaceuticalsIndia | 18 July 2023 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 46708-598-10 | Alembic PharmaceuticalsIndia | 5 April 2023 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 62332-598-05 | Alembic PharmaceuticalsIndia | 18 July 2023 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 62332-598-10 | Alembic PharmaceuticalsIndia | 5 April 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 24208-630-05 | Bausch & Lomb | 28 May 2021 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-630-10 | Bausch & Lomb | 28 May 2021 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 82260-630-05 | Bausch & Lomb Americas | 28 May 2021 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 82260-630-10 | Bausch & Lomb Americas | 28 May 2021 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 0378-7055-35 | Mylan Pharmaceuticals | 28 May 2021 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 0378-7055-67 | Mylan Pharmaceuticals | 28 May 2021 |
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 8 September 2009 | 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 Bepotastine 15 mg/mL eye drops.
Other strengths and forms of Bepotastine
Clinical summary
Bepotastine is a histamine-1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. It is available as eye drops and ophthalmic solution. MedsAcross supplies Bepotastine 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 BepotastineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Bepotastine Besilate prescribing information (Bausch & Lomb Americas) · U.S. National Library of Medicine, DailyMed
Need Bepotastine 15 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.