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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-624
Application NumberNDA216018
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ranolazine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-625
Application NumberNDA216018
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ranolazine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2022
FDA Product Classification
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