NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride CapsulesRx Only
Approved
Approval ID
cb902af0-b5ad-4680-b2f2-007ef2196efe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2023
Manufacturers
FDA
Burel Pharmaceuticals, LLC
DUNS: 609436204
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 Code35573-457
Application NumberANDA215377
Product Classification
M
Marketing Category
C73584
G
Generic Name
nicardipine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2023
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
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
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: K5BC5011K3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
nicardipine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35573-458
Application NumberANDA215377
Product Classification
M
Marketing Category
C73584
G
Generic Name
nicardipine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2023
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NICARDIPINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: K5BC5011K3
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
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
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT