ASPRUZYO SPRINKLE
These highlights do not include all the information needed to use ASPRUZYO SPRINKLE safely and effectively. See full prescribing information for ASPRUZYO SPRINKLE.ASPRUZYO SPRINKLE (ranolazine) extended-release granules, for oral useInitial U.S. Approval: 2006
Approved
Approval ID
dd9f81e4-50da-4551-aed5-559d304df42e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2022
Manufacturers
FDA
SUN PHARMACEUTICAL INDUSTRIES, INC.
DUNS: 146974886
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 Code47335-624
Application NumberNDA216018
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 2, 2022
Generic NameRanolazine
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
RANOLAZINEActive
Quantity: 500 mg in 1 1
Code: A6IEZ5M406
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
Ranolazine
PRODUCT DETAILS
NDC Product Code47335-625
Application NumberNDA216018
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 2, 2022
Generic NameRanolazine
INGREDIENTS (9)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
RANOLAZINEActive
Quantity: 1000 mg in 1 1
Code: A6IEZ5M406
Classification: ACTIB