FDA.reportPublic FDA data

Viagra

Product NDC
43353-764
11-digit product format
433530764
Labeler code
43353
Product ID
43353-764_ba60c834-54c3-4aa7-bb56-8bd769b7b39e
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
25 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
43353-764-022023-01-30C16284748780-1f386c649-9be3-0266-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
43353-764-042023-01-30C16284748780-1f386c649-9be3-0266-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
43353-764-062023-01-30C16284748780-1f386c649-9be3-0266-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
43353-764-122023-01-30C16284748780-1f386c649-9be3-0266-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
43353-764-02Viagra2 in 1 BOTTLE, PLASTICTABLET, FILM COATED23
43353-764-04Viagra4 in 1 BOTTLE, PLASTICTABLET, FILM COATED43
43353-764-06Viagra6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63
43353-764-12Viagra12 in 1 BOTTLE, PLASTICTABLET, FILM COATED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-764-02EA - Each43353-764aa294687-81ae-47fc-8e9c-78da7c636bb112014-05-02
43353-764-04EA - Each43353-764c1e629f3-c2a9-4360-8518-63a29bc5ec8d12020-01-03
43353-764-06EA - Each43353-764565b35a2-8118-4e07-86a2-146102c98e5512014-05-02
43353-764-12EA - Each43353-7645bf53b64-c551-4ac2-b355-4e1c172d6b0912020-01-03

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
43353-764VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 4 package rows20191220_47af30e9-a189-4721-8c8f-652256df75a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSN47af30e9-a189-4721-8c8f-652256df75a13
213269Viagra 25 MG Oral TabletPSN47af30e9-a189-4721-8c8f-652256df75a13
213269sildenafil 25 MG Oral Tablet [Viagra]SBD47af30e9-a189-4721-8c8f-652256df75a13
314228sildenafil 25 MG Oral TabletSCD47af30e9-a189-4721-8c8f-652256df75a13
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY47af30e9-a189-4721-8c8f-652256df75a13
213269Viagra 25 MG (as sildenafil citrate) Oral TabletSY47af30e9-a189-4721-8c8f-652256df75a13
213269Viagra 25 MG Oral TabletSY47af30e9-a189-4721-8c8f-652256df75a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-764-02433530764022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-02) 2011-11-200000-00-00NoNoCurrent
43353-764-04433530764044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-04) 2015-03-130000-00-00NoNoCurrent
43353-764-06433530764066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-06) 2011-11-190000-00-00NoNoCurrent
43353-764-124335307641212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-12) 2015-03-150000-00-00NoNoCurrent