Viagra
These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. VIAGRA® (sildenafil citrate) tablets, for oral useInitial U.S. Approval: 1998
Approved
Approval ID
c6c048ec-0b99-4fa4-9df7-9926db93749b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2015
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sildenafil citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4706
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2015
FDA Product Classification
INGREDIENTS (11)
SILDENAFIL CITRATEActive
Quantity: 100 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
sildenafil citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4084
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2015
FDA Product Classification
INGREDIENTS (11)
SILDENAFIL CITRATEActive
Quantity: 50 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
sildenafil citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4784
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2015
FDA Product Classification
INGREDIENTS (11)
SILDENAFIL CITRATEActive
Quantity: 25 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT