Sildenafil
These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
dc998a9c-0770-111b-e053-2a95a90a88a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2022
Manufacturers
FDA
Reyoung Corporation
DUNS: 118009917
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sildenafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82647-212
Application NumberANDA208494
Product Classification
M
Marketing Category
C73584
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2022
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 100 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
sildenafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82647-210
Application NumberANDA208494
Product Classification
M
Marketing Category
C73584
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2022
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 25 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
sildenafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82647-211
Application NumberANDA208494
Product Classification
M
Marketing Category
C73584
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2022
FDA Product Classification
INGREDIENTS (12)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 50 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM