Silodosin
These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN CAPSULE, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
58af9a98-b1a1-4f30-b535-6647f1effed4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2022
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
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 Code33342-385
Application NumberANDA211166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Silodosin
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2022
FDA Product Classification
INGREDIENTS (11)
SILODOSINActive
Quantity: 8 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
Silodosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-384
Application NumberANDA211166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Silodosin
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2022
FDA Product Classification
INGREDIENTS (10)
SILODOSINActive
Quantity: 4 mg in 1 1
Code: CUZ39LUY82
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT