Medicine
Ciprofloxacin 0.5 mg/0.25 mL ear drops
Ciprofloxacin 0.5 mg/0.25 mL ear drops is a generic prescription medicine for otic 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
Store at 15°C to 25°C (59°F to 77°F). Store unused containers in pouch to…
Key facts
- Active ingredient (INN)
- Ciprofloxacin
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/0.25 mL
- Dosage form
- Ear drops
- Route
- Otic
- Packs
- 14 vials
- Manufacturers
- Alembic PharmaceuticalsIndiaGenus Lifesciences
- Origin register
- US FDA, United States
- Storage
- Store at 15°C to 25°C (59°F to 77°F). Store unused containers in pouch to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01MA02 Ciprofloxacin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2024
- Identifiers
- RxCUI 848956DailyMed set ID 3e3c3813-7dd2-4655-9b0a-1fa7ff0e4dc1, 51dde3f2-adb1-4ed8-83c6-1f63723a2529NDC 62332-168, 64950-381Application ANDA217887
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 |
|---|---|---|---|
| 14 vial in 1 carton / .25 mL in 1 vial | 62332-168-25 | Alembic PharmaceuticalsIndia | 2 November 2026 |
| 14 vial in 1 carton / .25 mL in 1 vial | 64950-381-14 | Genus Lifesciences | 1 December 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 22 October 1987 | 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 Ciprofloxacin
Clinical summary
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated, among other approved uses. MedsAcross supplies Ciprofloxacin 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 CiprofloxacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cipro prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ciprofloxacin 0.5 mg/0.25 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.