Medicine
Gatifloxacin 5 mg/mL ophthalmic solution
Gatifloxacin 5 mg/mL ophthalmic solution 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
Protect from freezing. Store at 15°C to 25°C (59°F to 77°F).
Key facts
- Active ingredient (INN)
- Gatifloxacin
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle, 2.5 mL
- Manufacturers
- Caplin SterilesIndiaLeading Pharma
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. 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
- ATC code
- J01MA16 Gatifloxacin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 October 2025
- Identifiers
- RxCUI 992395DailyMed set ID 826cf8c4-4be5-4614-bd42-47c1d0c9df58, 2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523NDC 69315-331, 65145-207Application ANDA213542
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 / 2.5 mL in 1 bottle | 65145-207-01 | Caplin SterilesIndia | 6 October 2025 |
| 2.5 mL in 1 bottle | 69315-331-02 | Leading Pharma | 6 October 2025 |
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 28 March 2003 | 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 Gatifloxacin
Clinical summary
Gatifloxacin is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. It is available as eye drops and ophthalmic solution. MedsAcross supplies Gatifloxacin 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 GatifloxacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZYMAXID prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Gatifloxacin 5 mg/mL ophthalmic solution 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.