Aliskiren
These highlights do not include all the information needed to use Aliskiren safely and effectively. See full prescribing information for Aliskiren.Aliskiren tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
41c0e5e0-eb26-4d9e-bcd2-d0f2cc8fc6db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2023
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aliskiren hemifumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-142
Application NumberNDA021985
Product Classification
M
Marketing Category
C73605
G
Generic Name
aliskiren hemifumarate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALISKIREN HEMIFUMARATEActive
Quantity: 300 mg in 1 1
Code: C8A0P8G029
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
aliskiren hemifumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-141
Application NumberNDA021985
Product Classification
M
Marketing Category
C73605
G
Generic Name
aliskiren hemifumarate
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2023
FDA Product Classification
INGREDIENTS (11)
ALISKIREN HEMIFUMARATEActive
Quantity: 150 mg in 1 1
Code: C8A0P8G029
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT