NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE INJECTION 25mg/10mL (2.5 mg/mL) 10mL VIAL
Approved
Approval ID
9d898911-d811-2a78-e053-2995a90af784
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1482
Application NumberNDA022276
Product Classification
M
Marketing Category
C73594
G
Generic Name
NICARDIPINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 23, 2020
FDA Product Classification
INGREDIENTS (4)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 25 mg in 10 mL
Code: K5BC5011K3
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
2,4-DIHYDROXYBENZOIC ACIDInactive
Code: LU39SC9JYL
Classification: IACT