Medicine
Ofloxacin 3 mg/mL otic solution
Ofloxacin 3 mg/mL otic solution is a generic prescription medicine for otic use, made by 16 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 20º to 25°C (68º to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Ofloxacin
- Brand
- Sold under the generic name
- Strength
- 3 mg/mL
- Dosage form
- Otic solution
- Route
- Otic
- Packs
- 5 mL, 10 mL, 1 bottle and 36 more
- Manufacturers
- Lifestar PharmaIndiaA-S Medication SolutionsRemedyrepackBryant Ranch PrepackNuCare Pharmaceuticals,IncProficient RxAmneal Pharmaceuticals NYApotexAsclemedBausch & Lomb
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25°C (68º to 77°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 242446DailyMed set ID 79074efc-83ed-4473-bb86-9f635928ea92, 0621700e-6315-47ff-a8ed-cccf7d6fc56a, 8db221b1-32f3-f6ca-e404-71f56a860d08 +27NDC 82804-061, 70756-610, 60505-0363 +31Application ANDA216130, ANDA076527, ANDA076128 +3
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 | 70756-609-15 | Lifestar PharmaIndia | 15 July 2022 |
| 10 mL in 1 bottle, dropper | 70756-610-30 | Lifestar PharmaIndia | 15 July 2022 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 69238-1615-3 | Amneal Pharmaceuticals NY | 17 March 2020 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 69238-1616-6 | Amneal Pharmaceuticals NY | 30 August 2019 |
| 5 mL in 1 bottle, dropper | 60505-0363-1 | Apotex | 14 May 2004 |
| 10 mL in 1 bottle, dropper | 60505-0363-2 | Apotex | 14 May 2004 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 24208-410-05 | Bausch & Lomb | 17 March 2008 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-410-10 | Bausch & Lomb | 17 March 2008 |
| 5 mL in 1 bottle, dropper | 69315-320-05 | Leading Pharma | 1 March 2024 |
| 10 mL in 1 bottle, dropper | 69315-320-10 | Leading Pharma | 1 March 2024 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 64980-432-01 | Rising Pharma Holdings | 1 July 2022 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 64980-432-05 | Rising Pharma Holdings | 1 July 2022 |
| 5 mL in 1 bottle, dropper | 50090-1090-0 | A-S Medication Solutions | 28 November 2014 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-5670-0 | A-S Medication Solutions | 15 September 2021 |
| 5 mL in 1 bottle, dropper | 50090-7207-0 | A-S Medication Solutions | 5 August 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-8182-0 | A-S Medication Solutions | 4 November 2026 |
| 5 mL in 1 bottle, dropper | 70518-3984-0 | Remedyrepack | 14 January 2024 |
| 10 mL in 1 bottle, dropper | 70518-4147-0 | Remedyrepack | 22 July 2024 |
| 5 mL in 1 bottle, dropper | 70518-4226-0 | Remedyrepack | 31 October 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70518-4752-0 | Remedyrepack | 16 September 2026 |
| 5 mL in 1 bottle, dropper | 63629-8716-1 | Bryant Ranch Prepack | 14 May 2004 |
| 5 mL in 1 bottle, dropper | 71335-2822-1 | Bryant Ranch Prepack | 30 October 2025 |
| 5 mL in 1 bottle, dropper | 72162-1709-2 | Bryant Ranch Prepack | 20 September 2024 |
| 5 mL in 1 bottle | 68071-1588-5 | NuCare Pharmaceuticals,Inc | 5 November 2018 |
| 10 mL in 1 bottle | 68071-1630-3 | NuCare Pharmaceuticals,Inc | 28 September 2018 |
| 10 mL in 1 bottle, dropper | 68071-3604-3 | NuCare Pharmaceuticals,Inc | 31 July 2024 |
| 5 mL in 1 bottle, dropper | 63187-184-05 | Proficient Rx | 1 January 2019 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-472-05 | Proficient Rx | 2 February 2015 |
| 5 mL in 1 bottle, dropper | 82804-061-05 | Proficient Rx | 1 January 2024 |
| 5 mL in 1 bottle, dropper | 76420-748-05 | Asclemed | 12 June 2024 |
| 10 mL in 1 bottle, dropper | 76420-749-10 | Asclemed | 12 June 2024 |
| 5 mL in 1 bottle, dropper | 72189-108-05 | Direct RX | 8 June 2020 |
| 5 mL in 1 bottle, dropper | 72189-490-05 | Direct_Rx | 8 June 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 67296-1925-1 | Redpharm Drug | 17 March 2008 |
| 5 mL in 1 bottle, dropper | 67296-2159-5 | Redpharm Drug | 1 March 2024 |
| 5 mL in 1 bottle, dropper | 85766-226-05 | Sportpharm | 26 June 2026 |
| 10 mL in 1 bottle, dropper | 85766-227-10 | Sportpharm | 26 June 2026 |
| 5 mL in 1 bottle, dropper | 72603-186-01 | NorthStar RxLLC | 1 December 2023 |
| 10 mL in 1 bottle, dropper | 72603-186-02 | NorthStar RxLLC | 1 December 2023 |
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 otic 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.