Silodosin
SILODOSIN capsules, for oral use These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. Initial U.S. Approval: 2008
Approved
Approval ID
ea3bbafb-d32a-d0d3-e053-2a95a90ac387
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silodosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-777
Application NumberANDA209745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Silodosin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (14)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
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
SILODOSINActive
Quantity: 4 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
Silodosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-778
Application NumberANDA209745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Silodosin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (15)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
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
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
SILODOSINActive
Quantity: 8 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT