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 use Initial U.S. Approval: 1988
Approved
Approval ID
dcd7d173-4d8e-4282-9edf-817711340e43
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2021
Manufacturers
FDA
AuroMedics Pharma LLC
DUNS: 968961354
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 Code55150-183
Application NumberANDA211121
Product Classification
M
Marketing Category
C73584
G
Generic Name
NICARDIPINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (5)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 25 mg in 10 mL
Code: K5BC5011K3
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SORBITOLInactive
Quantity: 480 mg in 10 mL
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT