Medicine
Ciprofloxacin and Hydrocortisone 2 mg/10 mg per mL otic suspension
Ciprofloxacin and Hydrocortisone 2 mg/10 mg per mL otic suspension 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
Avoid freezing. Store at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Ciprofloxacin and Hydrocortisone
- Brand
- Sold under the generic name
- Strength
- 2 mg/10 mg per mL
- Dosage form
- Otic suspension
- Route
- Otic
- Packs
- 1 bottle
- Manufacturers
- Cosette PharmaceuticalsSandoz
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 March 1999
- Identifiers
- RxCUI 309305DailyMed set ID 6848cb55-7ca4-40ca-9751-f1fc262b8336, c0881bbe-cc95-45d4-9878-3bc8946eff26NDC 0713-0851, 0781-6218Application ANDA218273, NDA020805
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 in 1 carton / 10 mL in 1 bottle | 0713-0851-09 | Cosette Pharmaceuticals | 4 December 2025 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 0781-6218-70 | Sandoz | 21 August 2026 |
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 10 February 1998 | 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 Ciprofloxacin and Hydrocortisone 2 mg/10 mg per mL otic suspension.
Clinical summary
Ciprofloxacin and Hydrocortisone is a fixed-dose combination of a corticosteroid, a fluoroquinolone antibacterial and a quinolone antimicrobial indicated for the treatment of acute otitis externa in adult and pediatric patients, among other approved uses. MedsAcross supplies Ciprofloxacin and Hydrocortisone 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 Ciprofloxacin and HydrocortisoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ciprofloxacin hydrochloride and hydrocortisone prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Ciprofloxacin and Hydrocortisone 2 mg/10 mg per mL otic suspension 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.