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
8e8611e0-7d8c-4f30-b53a-76c6588b6ef7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2023
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
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 Code42571-394
Application NumberANDA216420
Product Classification
M
Marketing Category
C73584
G
Generic Name
NICARDIPINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2023
FDA Product Classification
INGREDIENTS (4)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT