Nicardipine Hydrochloride
Rx only
Approved
Approval ID
52e42bf6-34a3-4b95-9907-5e8d19108d47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2009
Manufacturers
FDA
Emcure Pharmaceuticals Ltd.
DUNS: 916921919
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 Code14593-124
Application NumberANDA090125
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT