Corlanor
These highlights do not include all the information needed to use CORLANOR safely and effectively. See full prescribing information for CORLANOR . CORLANOR ( ivabradine ) t ablets , for oral use CORLANOR (ivabradine) oral solution Initial U.S. Approval: 2015
Approved
Approval ID
92018a65-38f6-45f7-91d4-a34921b81d0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2022
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ivabradine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-800
Application NumberNDA206143
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivabradine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2022
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
IVABRADINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: TP19837BZK
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ivabradine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-810
Application NumberNDA206143
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivabradine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2022
FDA Product Classification
INGREDIENTS (12)
IVABRADINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: TP19837BZK
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ivabradine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-813
Application NumberNDA209964
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivabradine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2022
FDA Product Classification
INGREDIENTS (3)
IVABRADINE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: TP19837BZK
Classification: ACTIM
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT