Nicardipine Hydrochloride
Nicardipine Hydrochloride Injection
Approved
Approval ID
be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2009
Manufacturers
FDA
PharmaForce, Inc.
DUNS: 113894740
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 Code40042-047
Application NumberANDA090534
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 9, 2009
FDA Product Classification
INGREDIENTS (5)
SORBITOLInactive
Quantity: 48 mg in 1 mL
Code: 506T60A25R
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT