FDA.reportPublic FDA data

Viagra

Product NDC
67544-355
11-digit product format
675440355
Labeler code
67544
Product ID
67544-355_1e2ef63b-a8cf-45b8-89a1-f115038ecbd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020895
Marketing category
NDA
Marketing start
1998-03-27
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-355-022023-01-30C16284748780-1f386c649-9f22-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 1998
67544-355-042023-01-30C16284748780-1f386c649-9f22-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 1998
67544-355-062023-01-30C16284748780-1f386c649-9f22-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 1998
67544-355-122023-01-30C16284748780-1f386c649-9f22-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 1998
67544-355-522023-01-30C16284748780-1f386c649-9f22-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 1998
67544-355-742023-01-30C16284748780-1f386c649-9f22-0266-e053-dadaa90a7c1aThese 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 use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-355-02Viagra2 in 1 BOTTLE, PLASTICTABLET, FILM COATED23
67544-355-04Viagra4 in 1 BOTTLE, PLASTICTABLET, FILM COATED43
67544-355-06Viagra6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63
67544-355-12Viagra12 in 1 BOTTLE, PLASTICTABLET, FILM COATED123
67544-355-52Viagra18 in 1 BOTTLE, PLASTICTABLET, FILM COATED183
67544-355-74Viagra9000 in 1 BOTTLE, PLASTICTABLET, FILM COATED90003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-355-02EA - Each67544-35593627690-ef40-4841-a51f-386e9e7a426f12014-05-02
67544-355-04EA - Each67544-355ccf8a20f-fb5b-41e7-8612-da38d5254efc12014-05-02
67544-355-06EA - Each67544-355004b0009-30b3-4aab-910d-0bed9751c80312014-05-02
67544-355-12EA - Each67544-355091ad9a1-3c79-49c1-84f7-1149635a92c612014-05-02
67544-355-52EA - Each67544-355836a35a4-262d-42fb-b9a1-d8bca763238b12014-05-02
67544-355-74EA - Each67544-355f72f48b5-eef1-497c-8d14-c4926d01074a12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILDENAFILACTIVE MOIETY3M7OB98Y7HVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-355VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 6 package rows20191227_c8d046c9-d9e9-4660-8ff1-a6c23b16eb3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
312950sildenafil citrate 50 MG Oral TabletPSNc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213271Viagra 100 MG Oral TabletPSNc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213270Viagra 50 MG Oral TabletPSNc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213271sildenafil 100 MG Oral Tablet [Viagra]SBDc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213270sildenafil 50 MG Oral Tablet [Viagra]SBDc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
314229sildenafil 100 MG Oral TabletSCDc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
312950sildenafil 50 MG Oral TabletSCDc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213271Viagra 100 MG (as sildenafil citrate) Oral TabletSYc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213271Viagra 100 MG Oral TabletSYc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213270Viagra 50 MG (as sildenafil citrate) Oral TabletSYc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3
213270Viagra 50 MG Oral TabletSYc8d046c9-d9e9-4660-8ff1-a6c23b16eb3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-355-02675440355022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-02) 2005-05-200000-00-00NoNoCurrent
67544-355-04675440355044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-04) 2005-05-200000-00-00NoNoCurrent
67544-355-06675440355066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-06) 2011-11-150000-00-00NoNoCurrent
67544-355-126754403551212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-12) 2011-11-210000-00-00NoNoCurrent
67544-355-526754403555218 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-52) 2011-11-200000-00-00NoNoCurrent
67544-355-74675440355749000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-355-74) 2013-06-280000-00-00NoNoCurrent