Medicine
Azelastine 0.5 mg/mL eye drops
Azelastine 0.5 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store UPRIGHT between 2° and 25°C (36° and 77°F).
Key facts
- Active ingredient (INN)
- Azelastine
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle
- Manufacturers
- Alembic PharmaceuticalsIndiaSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store UPRIGHT between 2° and 25°C (36° and 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R01AC03 Azelastine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 March 2019
- Identifiers
- RxCUI 860805DailyMed set ID 72406ded-7886-41fb-b5c8-2d27a149aa34, 753d7a69-b0da-4350-9dc5-97f26ebe5cc0, 7532ed82-5cfa-49da-83e5-c57ffdd3adbbNDC 70069-091, 46708-506, 62332-506Application ANDA207411, ANDA209620
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 / 6 mL in 1 bottle | 46708-506-06 | Alembic PharmaceuticalsIndia | 20 March 2019 |
| 1 bottle in 1 carton / 6 mL in 1 bottle | 62332-506-06 | Alembic PharmaceuticalsIndia | 20 March 2019 |
| 1 bottle in 1 carton / 6 mL in 1 bottle | 70069-091-01 | Somerset Therapeutics | 8 April 2019 |
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 1 November 1996 | 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 Azelastine
Clinical summary
Azelastine is a histamine-1 receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults, among other approved uses. MedsAcross supplies Azelastine 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 AzelastineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Azelastine Hydrochloride prescribing information (Apotex) · U.S. National Library of Medicine, DailyMed
Need Azelastine 0.5 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.