IVABRADINE
IVABRADINE TABLETS. 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
236cc914-7eef-600c-e063-6394a90a4bd1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2025
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 2
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 Code51407-593
Application NumberANDA214051
Product Classification
M
Marketing Category
C73584
G
Generic Name
IVABRADINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
IVABRADINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: TP19837BZK
Classification: ACTIM
IVABRADINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-592
Application NumberANDA214051
Product Classification
M
Marketing Category
C73584
G
Generic Name
IVABRADINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
IVABRADINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: TP19837BZK
Classification: ACTIM