Nicardipine Hydrochloride
NICARDIPINE HYDROCHLORIDE INJECTION Rx Only These highlights do not include all the information needed to use NICARDIPINE HYDROCHLORIDE safely and effectively. See full prescribing information for NICARDIPINE HYDROCHLORIDE. NICARDIPINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1988
Approved
Approval ID
0eb7d839-63d9-4b51-bf7b-4a8fde6339b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
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 Code0143-9593
Application NumberNDA022276
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
2,4-DIHYDROXYBENZOIC ACIDInactive
Quantity: .305 mg in 1 mL
Code: LU39SC9JYL
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 7.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT