Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ALISKIREN
Product Details
NDC Product Code
49884-425Application Number
ANDA206665Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 25, 2019AliskirenActive
Code: C8A0P8G029Class: ACTIMQuantity: 300 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALISKIREN
Product Details
NDC Product Code
49884-424Application Number
ANDA206665Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 25, 2019AliskirenActive
Code: C8A0P8G029Class: ACTIMQuantity: 150 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT