Nicardipine Hydrochloride
Nicardipine Hydrochloride Capsules 20 mg and 30 mg Rx only
Approved
Approval ID
b8f147b8-955f-4733-9178-2cfa0beb60d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
Products 2
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 Code42806-501
Application NumberANDA074928
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: K5BC5011K3
Classification: ACTIB
Nicardipine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-502
Application NumberANDA074928
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicardipine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: K5BC5011K3
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT