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
c8d046c9-d9e9-4660-8ff1-a6c23b16eb3f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
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 Code67544-355
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2014
FDA Product Classification
INGREDIENTS (11)
SILDENAFIL CITRATEActive
Quantity: 50 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
sildenafil citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67544-356
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2014
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 100 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT