Ranolazine
These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
896ea7ab-8714-4e8b-a194-5b0bde318032
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranolazine
PRODUCT DETAILS
NDC Product Code45963-418
Application NumberANDA208862
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2022
Generic NameRanolazine
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RANOLAZINEActive
Quantity: 500 mg in 1 1
Code: A6IEZ5M406
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Ranolazine
PRODUCT DETAILS
NDC Product Code45963-419
Application NumberANDA208862
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2022
Generic NameRanolazine
INGREDIENTS (13)
RANOLAZINEActive
Quantity: 1000 mg in 1 1
Code: A6IEZ5M406
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT