Medicine
Ofloxacin 3 mg/mL ophthalmic solution
Ofloxacin 3 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 10 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 25°C (77°F), excursions permitted from 15 to 30°C (59 to 86°F)…
Key facts
- Active ingredient (INN)
- Ofloxacin
- Brand
- Sold under the generic name
- Strength
- 3 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle, 5 mL, 10 mL and 16 more
- Manufacturers
- Micro LabsIndiaA-S Medication SolutionsProficient RxApotexLeading PharmaNuCare Pharmaceuticals,IncRising Pharma HoldingsSt. Mary's Medical Park PharmacyAltaire PharmaceuticalsPreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted from 15 to 30°C (59 to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01MA12 Ofloxacin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 May 2013
- Identifiers
- RxCUI 312075DailyMed set ID 5117d567-2004-c5ed-1391-f8831864696f, 27c247e5-ef93-e9a5-e063-6394a90a2e1e, 102c825b-af5c-42e7-e063-6394a90a81a1 +12NDC 60505-0560, 60760-970, 68071-3566 +12Application ANDA076513, ANDA078559, ANDA217904 +2
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, dropper in 1 carton / 5 mL in 1 bottle, dropper | 42571-461-92 | Micro LabsIndia | 15 October 2026 |
| 5 mL in 1 bottle, dropper | 59390-140-05 | Altaire Pharmaceuticals | 31 May 2013 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 60505-0560-0 | Apotex | 1 March 2019 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 60505-0560-1 | Apotex | 1 March 2019 |
| 5 mL in 1 bottle, dropper | 69315-327-05 | Leading Pharma | 15 July 2024 |
| 10 mL in 1 bottle, dropper | 69315-327-10 | Leading Pharma | 15 July 2024 |
| 1 bottle, plastic in 1 carton / 10 mL in 1 bottle, plastic | 64980-515-01 | Rising Pharma Holdings | 1 November 2017 |
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 64980-515-05 | Rising Pharma Holdings | 1 November 2017 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 50090-5186-0 | A-S Medication Solutions | 29 September 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-5209-0 | A-S Medication Solutions | 5 October 2020 |
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 50090-5425-0 | A-S Medication Solutions | 8 January 2021 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 68071-3566-1 | NuCare Pharmceuticals,Inc | 30 January 2024 |
| 10 mL in 1 bottle, dropper | 68071-5337-1 | NuCare Pharmaceuticals | 9 October 2026 |
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 63187-734-05 | Proficient Rx | 1 July 2016 |
| 1 bottle, plastic in 1 carton / 10 mL in 1 bottle, plastic | 63187-734-10 | Proficient Rx | 1 July 2016 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 71205-420-05 | Proficient Rx | 1 March 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 60760-917-05 | St. Mary's Medical Park Pharmacy | 29 January 2025 |
| 1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic | 60760-970-05 | ST. Mary's Medical Park Pharmacy | 22 November 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68788-8761-5 | Preferred Pharmaceuticals | 11 November 2024 |
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 December 1990 | 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 Ofloxacin
Clinical summary
Ofloxacin is a quinolone antimicrobial indicated for the treatment of infections caused by susceptible strains of bacteria in the conditions listed below. It is available as otic solution, eye drops and ophthalmic solution for oral use. MedsAcross supplies Ofloxacin 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 OfloxacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- OCUFLOX prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Ofloxacin 3 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.