Cleviprex
These highlights do not include all the information needed to use Cleviprex safely and effectively. See full prescribing information for Cleviprex. Cleviprex (clevidipine) injectable emulsion, for intravenous use Initial U.S. Approval: 2008
Approved
Approval ID
a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2022
Manufacturers
FDA
Fresenius Kabi Austria GmbH
DUNS: 303448575
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clevidipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code18124-011
Application NumberNDA022156
Product Classification
M
Marketing Category
C73594
G
Generic Name
clevidipine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 28, 2018
FDA Product Classification
INGREDIENTS (7)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CLEVIDIPINEActive
Quantity: 0.5 mg in 1 mL
Code: 19O2GP3B7Q
Classification: ACTIB