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 useInitial U.S. Approval: 2006
Approved
Approval ID
7610b62e-bdf5-47bd-8bbf-37654ab727bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals
DUNS: 039452765
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 Code70436-103
Application NumberANDA213085
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 25, 2023
Generic Nameranolazine
INGREDIENTS (13)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
RANOLAZINEActive
Quantity: 500 mg in 1 1
Code: A6IEZ5M406
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ranolazine
PRODUCT DETAILS
NDC Product Code70436-104
Application NumberANDA213085
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 25, 2023
Generic Nameranolazine
INGREDIENTS (14)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
RANOLAZINEActive
Quantity: 1000 mg in 1 1
Code: A6IEZ5M406
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT