Medicine
Ofloxacin 3 mg/mL ear drops
Ofloxacin 3 mg/mL ear drops is a generic prescription medicine for otic use, made by 4 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 to 15°-30°C (59-86 °F). Protect…
Key facts
- Active ingredient (INN)
- Ofloxacin
- Brand
- Sold under the generic name
- Strength
- 3 mg/mL
- Dosage form
- Ear drops
- Route
- Otic
- Packs
- 1 bottle and 3 more
- Manufacturers
- Caplin SterilesIndiaSomerset TherapeuticsPreferred PharmaceuticalsRedpharm Drug
- Origin register
- US FDA, United States
- Storage
- Store at 25 °C (77 °F), excursions permitted to 15°-30°C (59-86 °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 October 2024
- Identifiers
- RxCUI 242446DailyMed set ID 3dd035d0-c3ec-3fc2-e063-6294a90a4aac, 72ad7b86-1d5b-48c9-bb40-319d6c186f1d, 2bb61a24-87a6-4e74-a319-fc5e7c483bbb +1NDC 67296-2179, 70069-687, 65145-143 +3Application ANDA216328, ANDA217903
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 | 65145-143-01 | Caplin SterilesIndia | 16 December 2024 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 65145-144-01 | Caplin SterilesIndia | 16 December 2024 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 70069-686-01 | Somerset Therapeutics | 31 October 2024 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 70069-687-01 | Somerset Therapeutics | 31 October 2024 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 68788-4086-1 | Preferred Pharmaceuticals | 17 March 2026 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 67296-2179-5 | Redpharm Drug | 31 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
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 ear 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.