Nicardipine Hydrochloride
These highlights do not include all the information needed to use NICARDIPINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for NICARDIPINE HYDROCHLORIDE INJECTION. NICARDIPINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1988
Approved
Approval ID
30fb3a4d-fa75-42fd-b4b6-2a21f202027f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2020
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nicardipine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72572-470
Application NumberANDA090534
Product Classification
M
Marketing Category
C73584
G
Generic Name
nicardipine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 1, 2020
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.525 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.04 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SORBITOLInactive
Quantity: 48 mg in 1 mL
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 0.09 mg in 1 mL
Code: 55X04QC32I
Classification: IACT