Silodosin
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . SILODOSIN capsules, for oral useInitial U.S. Approval: 2008
Approved
Approval ID
455c98be-aa01-4393-915f-34d1859005c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2022
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silodosin
PRODUCT DETAILS
NDC Product Code60219-1421
Application NumberANDA209745
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameSilodosin
INGREDIENTS (14)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILODOSINActive
Quantity: 4 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Silodosin
PRODUCT DETAILS
NDC Product Code60219-1420
Application NumberANDA209745
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameSilodosin
INGREDIENTS (15)
SILODOSINActive
Quantity: 8 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT