Nicardipine Hydrochloride
These highlights do not include all the information needed to use Nicardipine hydrochloride injection, USP safely and effectively. See full prescribing information for Nicardipine hydrochloride injection. Nicardipine hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1988
Approved
Approval ID
e61159ba-ff6b-4696-a642-4f64c79c4708
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2023
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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 Code64679-631
Application NumberANDA090671
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 11, 2023
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: K5BC5011K3
Classification: ACTIB