Medicine
Olopatadine 1 mg/mL eye drops
Olopatadine 1 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 4° to 25°C (39° to 77°F) Rx Only Manufactured for: Alembic…
Key facts
- Active ingredient (INN)
- Olopatadine
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle
- Manufacturer
- Alembic PharmaceuticalsIndia
- Origin register
- US FDA, United States
- Storage
- Store at 4° to 25°C (39° to 77°F) Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Manufactured by: Gland Pharma Limited D.P.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R01AC08 Olopatadine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 December 2018
- Identifiers
- RxCUI 1111339DailyMed set ID 7b36e554-d68a-47e0-bf3c-f4cfdc3746b6NDC 62332-501Application ANDA209919
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, plastic in 1 carton / 5 mL in 1 bottle, plastic | 62332-501-05 | Alembic PharmaceuticalsIndia | 7 December 2018 |
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.
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 Olopatadine
Clinical summary
Olopatadine is a histamine-1 receptor inhibitor indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. MedsAcross supplies Olopatadine 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 OlopatadineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Olopatadine Hydrochloride prescribing information (Apotex) · U.S. National Library of Medicine, DailyMed
- Opatanol: European public assessment report (EPAR) · European Medicines Agency
Need Olopatadine 1 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.