Prescription medicine
Clevidipine Brand names: Cleviprex
Clevidipine (Cleviprex) is a prescription medicine with an FDA approval on record since 2008. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the clevidipine FDA label on DailyMed (effective November 6, 2025, Chiesi USA, Inc.); the NDA 22156 record on Drugs@FDA; every clevidipine label on DailyMed.
Highlights of the record
FDA label of November 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Forms and strengths
- 0.5 mg/ml
Emulsion.
On the market
- Earliest approval on file
- August 1, 2008 Cleviprex, Chiesi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 10, 2031 Cleviprex injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest July 6, 2026
- FAERS reports
- 362 through July 30, 2026
What is clevidipine used for?
From the label: indications and usageCleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
FDA pharmacologic class: Dihydropyridine Calcium Channel Blocker.
Source: FDA drug label (Cleviprex), Chiesi USA, Inc., effective November 6, 2025 (SPL set f9290625-b723-4eda-bab8-a97bef6041f6), via openFDA; the full label on DailyMed
Is there a generic for clevidipine (Cleviprex)?
No generic clevidipine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Cleviprex injection, the last expiring on October 10, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has clevidipine been recalled?
The FDA's Enforcement Report lists 1 recall naming clevidipine since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 6, 2026 | Class II | Chiesi USA, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clevidipine label say about other medicines?
The clevidipine label names no other medicine on this site. The labels of 1 other medicine name clevidipine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Cleviprex), Chiesi USA, Inc., effective November 6, 2025 (SPL set f9290625-b723-4eda-bab8-a97bef6041f6), via openFDA; the full label on DailyMed
What do FAERS reports show for clevidipine?
The FDA Adverse Event Reporting System holds 362 reports that list clevidipine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 52 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other calcium channel blockers
- the pharmacologic class, with prices and generics
- Clevidipine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other