Medicine
Ofloxacin 3 mg/mL eye drops
Ofloxacin 3 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 14 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Ofloxacin
- Brand
- Sold under the generic name
- Strength
- 3 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 5 mL, 10 mL, 1 bottle and 30 more
- Manufacturers
- Caplin SterilesIndiaLifestar PharmaIndiaNuCare Pharmaceuticals,IncA-S Medication SolutionsProficient RxArmas PharmaceuticalsBausch & LombMajor PharmaceuticalsNorthStar RxLLCPreferred Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 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
- 14 May 2004
- Identifiers
- RxCUI 312075DailyMed set ID 53f7ec2e-5b4c-4f8c-b8ba-7f8844e0c01b, ff9776b3-a244-e1ea-e053-6294a90aeb7b, 4b2b893d-c19b-4c4a-85de-ff901325080b +22NDC 65145-141, 68071-3448, 65145-142 +24Application ANDA217904, ANDA215886, ANDA213597 +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 |
|---|---|---|---|
| 5 mL in 1 bottle, dropper | 65145-141-01 | Caplin SterilesIndia | 5 February 2025 |
| 10 mL in 1 bottle, dropper | 65145-142-01 | Caplin SterilesIndia | 5 February 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70756-607-30 | Lifestar PharmaIndia | 7 December 2022 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 70756-650-30 | Lifestar PharmaIndia | 25 August 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 72485-613-10 | Armas Pharmaceuticals | 14 October 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 72485-613-11 | Armas Pharmaceuticals | 14 October 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 24208-434-05 | Bausch & Lomb | 14 May 2004 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-434-10 | Bausch & Lomb | 14 May 2004 |
| 1 bottle, dropper in 1 box / 5 mL in 1 bottle, dropper | 70512-793-05 | SOLA Pharmaceuticals | 30 April 2024 |
| 1 bottle, dropper in 1 box / 10 mL in 1 bottle, dropper | 70512-793-10 | SOLA Pharmaceuticals | 30 April 2024 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 70069-411-01 | Somerset Therapeutics | 10 October 2024 |
| 5 mL in 1 box | 68071-1607-5 | NuCare Pharmaceuticals | 14 June 2017 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-2254-5 | NuCare Pharmaceuticals,Inc | 3 September 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-2265-1 | NuCare Pharmaceuticals,Inc | 17 September 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-3448-5 | NuCare Pharmaceuticals,Inc | 3 July 2023 |
| 5 mL in 1 bottle, dropper | 68071-3919-5 | NuCare Pharmaceuticals | 26 November 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-1744-0 | A-S Medication Solutions | 17 March 2015 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-6794-0 | A-S Medication Solutions | 1 November 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 50090-7264-0 | A-S Medication Solutions | 7 October 2024 |
| 5 mL in 1 bottle, dropper | 50090-7761-0 | A-S Medication Solutions | 10 November 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-268-05 | Proficient Rx | 1 January 2019 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-662-05 | Proficient Rx | 1 December 2018 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 63187-662-10 | Proficient Rx | 1 December 2018 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 82804-101-05 | Proficient Rx | 2 May 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68788-7693-5 | Preferred Pharmaceuticals | 1 April 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68788-8449-5 | Preferred Pharmaceuticals | 25 May 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 70518-3573-1 | Remedyrepack | 12 August 2026 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70518-3710-0 | Remedyrepack | 11 April 2023 |
| 5 mL in 1 carton | 72189-472-05 | Direct_Rx | 22 May 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 0904-7434-05 | Major Pharmaceuticals | 11 November 2024 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 0904-7434-10 | Major Pharmaceuticals | 11 November 2024 |
| 5 mL in 1 bottle, dropper | 72603-192-01 | NorthStar RxLLC | 1 December 2023 |
| 10 mL in 1 bottle, dropper | 72603-192-02 | NorthStar RxLLC | 1 October 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
Alternatives
Other makers and brands of Ofloxacin 3 mg/mL eye drops.
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 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.