Viagra

Product NDC
67544-356
11-digit product format
675440356
Labeler code
67544
Product ID
67544-356_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
100 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
67544-356-022023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-042023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-062023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-122023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-522023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-562023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-642023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-892023-01-30C16284748780-1f386c649-9f22-0266-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
67544-356-02Viagra2 in 1 BOTTLE, PLASTICTABLET, FILM COATED23
67544-356-04Viagra4 in 1 BOTTLE, PLASTICTABLET, FILM COATED43
67544-356-06Viagra6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63
67544-356-12Viagra12 in 1 BOTTLE, PLASTICTABLET, FILM COATED123
67544-356-52Viagra18 in 1 BOTTLE, PLASTICTABLET, FILM COATED183
67544-356-56Viagra3000 in 1 BOTTLE, PLASTICTABLET, FILM COATED30003
67544-356-64Viagra700 in 1 BOTTLE, PLASTICTABLET, FILM COATED7003
67544-356-89Viagra720 in 1 BOTTLE, PLASTICTABLET, FILM COATED7203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-356-02EA - Each67544-356fac6b173-c802-4e88-8a10-d94c4ea1d7c612014-05-02
67544-356-04EA - Each67544-356d8599625-9b98-4a3e-bdfb-c7bcdc1d58e912014-05-02
67544-356-06EA - Each67544-356d25ce10b-bc06-4846-9d29-c1313a72f6db12014-05-02
67544-356-12EA - Each67544-35655dbb99b-cc65-420d-86ea-74e41263c67d12014-05-02
67544-356-52EA - Each67544-356070e4711-8b28-4d8f-96f0-64e5eb01b78d12014-05-02
67544-356-56EA - Each67544-3567072a800-caff-45b7-bfdd-c597b7baf8f312014-06-03
67544-356-64EA - Each67544-356529a82d7-58e9-4754-b38a-37f463cc457212014-05-02
67544-356-89EA - Each67544-3567864e702-4109-4874-aa86-e5152e4c96d212014-05-02

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
67544-356VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 8 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
67544-356-02675440356022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-02) 2005-03-040000-00-00NoNoCurrent
67544-356-04675440356044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-04) 2005-03-040000-00-00NoNoCurrent
67544-356-06675440356066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-06) 2005-03-040000-00-00NoNoCurrent
67544-356-126754403561212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-12) 2005-03-040000-00-00NoNoCurrent
67544-356-526754403565218 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-52) 2011-11-200000-00-00NoNoCurrent
67544-356-56675440356563000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-56) 2013-06-270000-00-00NoNoCurrent
67544-356-6467544035664700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-64) 2012-02-200000-00-00NoNoCurrent
67544-356-8967544035689720 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-89) 2012-02-110000-00-00NoNoCurrent