ALISKIREN
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . , for oral use Initial U.S. Approval:
Approved
Approval ID
f3fd2503-25ef-4660-a29a-f62c491e28fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 25, 2019
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ALISKIREN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-425
Application NumberANDA206665
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALISKIREN
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2019
FDA Product Classification
INGREDIENTS (10)
ALISKIREN HEMIFUMARATEActive
Quantity: 300 mg in 1 1
Code: C8A0P8G029
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALISKIREN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-424
Application NumberANDA206665
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALISKIREN
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2019
FDA Product Classification
INGREDIENTS (11)
ALISKIREN HEMIFUMARATEActive
Quantity: 150 mg in 1 1
Code: C8A0P8G029
Classification: ACTIM
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT