Ivabradine
These highlights do not include all the information needed to use IVABRADINE TABLETS safely and effectively. See full prescribing information for IVABRADINE TABLETS. IVABRADINE tablets, for oral use Initial U.S. Approval: 2015
Approved
Approval ID
676907d3-b374-4baa-8422-c04706409540
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ivabradine
PRODUCT DETAILS
NDC Product Code72205-337
Application NumberANDA213483
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 28, 2025
Generic NameIvabradine
INGREDIENTS (13)
IVABRADINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: TP19837BZK
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Ivabradine
PRODUCT DETAILS
NDC Product Code72205-336
Application NumberANDA213483
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 28, 2025
Generic NameIvabradine
INGREDIENTS (13)
IVABRADINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: TP19837BZK
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT