Nicardipine Hydrochloride
Rx only
Approved
Approval ID
c84cda13-e2fb-46d6-a9a2-5a3311387ff8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2011
Manufacturers
FDA
Sandoz Inc.
DUNS: 110342024
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 Code0781-3204
Application NumberANDA090125
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 14, 2011
FDA Product Classification
INGREDIENTS (5)
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT