Medicine
Azasite 10 mg/mL eye drops
Azasite 10 mg/mL eye drops is a prescription medicine containing Azithromycin for ophthalmic use, marketed by Thea Pharma, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store unopened bottle under refrigeration at 2° to 8°C (36° to 46°F). Once the…
Key facts
- Active ingredient (INN)
- Azithromycin
- Brand
- Azasite
- Strength
- 10 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle
- Marketing authorisation holder
- Thea Pharma
- Manufacturer
- Thea Pharma
- Origin register
- US FDA, United States
- Storage
- Store unopened bottle under refrigeration at 2° to 8°C (36° to 46°F). Once the bottle is opened, store at 2° to 25°C (36° to 77°F) for up to 14 days.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01FA10 Azithromycin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2022
- Identifiers
- RxCUI 706868, 706872DailyMed set ID 0c5d6f5e-18ea-436f-8c62-bbaf66effe3dNDC 82584-307Application NDA050810
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, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 82584-307-03 | Thea Pharma | 1 November 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 1 November 1991 | 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 Azithromycin
Clinical summary
Azithromycin is a macrolide antimicrobial indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below, among other approved uses. MedsAcross supplies Azithromycin 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 AzithromycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zithromax prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Azasite 10 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.