Medicine
Ciprofloxacin and Dexamethasone 3 mg/1 mg per mL otic suspension
Ciprofloxacin and Dexamethasone 3 mg/1 mg per mL otic suspension is a generic prescription medicine for otic use, made by 12 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 to…
Key facts
- Active ingredient (INN)
- Ciprofloxacin and Dexamethasone
- Brand
- Sold under the generic name
- Strength
- 3 mg/1 mg per mL
- Dosage form
- Otic suspension
- Route
- Otic
- Packs
- 1 bottle and 12 more
- Manufacturers
- Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaNuCare Pharmaceuticals,IncRedpharm DrugAmneal Pharmaceuticals of New YorkArmas PharmaceuticalsNorthStar RxLLCSandozSentiss Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 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
- 10 August 2020
- Identifiers
- RxCUI 403908DailyMed set ID 130deaf4-ced5-abcb-2a01-205c640ddf96, 2f780550-ecbf-98fc-e063-6294a90a11c0, eed6b293-6bbe-4bd3-ad9d-3849e0eb6c05 +12NDC 16714-628, 68071-3804, 72485-625 +12Application ANDA205548, ANDA215768, ANDA210470 +4
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 / 7.5 mL in 1 bottle | 46708-776-75 | Alembic PharmaceuticalsIndia | 15 October 2026 |
| 1 bottle in 1 carton / 7.5 mL in 1 bottle | 62332-776-75 | Alembic PharmaceuticalsIndia | 15 October 2026 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 43598-326-75 | Dr. Reddy's LaboratoriesIndia | 10 August 2020 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 62756-427-90 | Sun Pharmaceutical IndustriesIndia | 1 September 2022 |
| 1 bottle, plastic in 1 carton / 7.5 mL in 1 bottle, plastic | 53746-831-53 | Amneal Pharmaceuticals of New York | 26 March 2024 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 72485-625-13 | Armas Pharmaceuticals | 1 November 2023 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 0781-6186-67 | Sandoz | 10 August 2020 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 70244-033-01 | Sentiss Pharmaceuticals | 16 April 2026 |
| 1 bottle in 1 carton / 7.5 mL in 1 bottle | 0832-1430-75 | Upsher-Smith Laboratories | 13 February 2026 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 68071-3804-7 | NuCare Pharmaceuticals | 3 March 2025 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 68071-3977-7 | NuCare Pharmaceutical | 19 March 2026 |
| 1 bottle, dropper in 1 carton / 8 mL in 1 bottle, dropper | 67296-1943-8 | Redpharm Drug | 1 November 2023 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 67296-2257-8 | Redpharm Drug | 1 August 2022 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 16714-628-01 | NorthStar RxLLC | 1 August 2022 |
| 1 bottle, dropper in 1 carton / 7.5 mL in 1 bottle, dropper | 85766-245-75 | Sportpharm | 13 July 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 18 July 2003 | 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
Clinical summary
Ciprofloxacin and Dexamethasone is a fixed-dose combination of a corticosteroid and a fluoroquinolone antibacterial indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below. MedsAcross supplies Ciprofloxacin and Dexamethasone 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 DexamethasoneFor 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 and Dexamethasone prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Ciprofloxacin and Dexamethasone 3 mg/1 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.