Medicine
Cleviprex 125 mg/250 mL injectable emulsion
Cleviprex 125 mg/250 mL injectable emulsion is a prescription medicine containing Clevidipine for intravenous use, marketed by Fresenius Kabi Austria, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store vials refrigerated at 2-8°C (36-46°F). Do not freeze. Upon transfer to…
Key facts
- Active ingredient (INN)
- Clevidipine
- Brand
- Cleviprex
- Strength
- 125 mg/250 mL
- Dosage form
- Injectable emulsion
- Route
- Intravenous
- Packs
- 4 cartons of 250 mL
- Marketing authorisation holder
- Fresenius Kabi Austria
- Manufacturer
- Fresenius Kabi Austria
- Origin register
- US FDA, United States
- Storage
- Store vials refrigerated at 2-8°C (36-46°F). Do not freeze. Upon transfer to room temperature, mark vials in cartons “This product was removed from the refrigerator on _/_/_ date. Vials in cartons may be transferred to 25°C (77°F, USP controlled room temperature) for a period not to exceed 2 months.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C08CA16 Clevidipine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 September 2008
- Identifiers
- RxCUI 1790239, 1790242, 1790245 +3DailyMed set ID a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330NDC 18124-011Application NDA022156
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 4 carton in 1 carton / 1 vial, single-use in 1 carton / 250 mL in 1 vial, single-use | 18124-011-25 | Fresenius Kabi Austria | 15 September 2008 |
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 1 August 2008 | 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 Clevidipine
Clinical summary
Clevidipine is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. It is available as injectable emulsion for intravenous use. MedsAcross supplies Clevidipine 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 ClevidipineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cleviprex prescribing information (Chiesi) · U.S. National Library of Medicine, DailyMed
Need Cleviprex 125 mg/250 mL injectable emulsion 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.