NICARDIPINE HYDROCHLORIDE
CARDENE(R) I.V. (NICARDIPINE HYDROCHLORIDE) PREMIXED INJECTION IN 4.8% DEXTROSE 20mg IN 200mL (0.1mg/mL) 200mL BAG
Approved
Approval ID
a14a6a4d-232b-634f-e053-2a95a90a2323
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 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 Code51662-1428
Application NumberNDA019734
Product Classification
M
Marketing Category
C73594
G
Generic Name
NICARDIPINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (4)
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.0192 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 48 mg in 1 mL
Code: LX22YL083G
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
SORBITOLInactive
Quantity: 1.92 mg in 1 mL
Code: 506T60A25R
Classification: IACT