FDA.reportPublic FDA data

Viagra

Product NDC
0069-4200
11-digit product format
000694200
Labeler code
0069
Product ID
0069-4200_b6b3d80f-fc7b-4235-a6cd-d5eab75b768c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PFIZER LABORATORIES DIV PFIZER INC
Application
NDA020895
Marketing category
NDA
Marketing start
1998-03-27
Marketing end
2027-09-30
Substance
SILDENAFIL CITRATE
Active strength
25 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Viagra

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui213269, 213270, 213271, 312950, 314228, 314229

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-4200-30Viagra30 in 1 BOTTLETABLET, FILM COATED3032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-4200-30EA - Each0069-4200114168be-fb87-4ccf-a76f-9cd8bcd06c2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
SILDENAFILACTIVE MOIETY3M7OB98Y7HVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
TRIACETININACTIVE INGREDIENTXHX3C3X673VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]18
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SILDENAFILACTIVE MOIETY3M7OB98Y7HVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
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
0069-4200VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]28Current NDC, Legacy NDC, 1 package rows20250406_0b0be196-0c62-461c-94f4-9a35339b4501.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN0b0be196-0c62-461c-94f4-9a35339b450132
314228sildenafil citrate 25 MG Oral TabletPSN0b0be196-0c62-461c-94f4-9a35339b450132
312950sildenafil citrate 50 MG Oral TabletPSN0b0be196-0c62-461c-94f4-9a35339b450132
213271Viagra 100 MG Oral TabletPSN0b0be196-0c62-461c-94f4-9a35339b450132
213269Viagra 25 MG Oral TabletPSN0b0be196-0c62-461c-94f4-9a35339b450132
213270Viagra 50 MG Oral TabletPSN0b0be196-0c62-461c-94f4-9a35339b450132
213271sildenafil 100 MG Oral Tablet [Viagra]SBD0b0be196-0c62-461c-94f4-9a35339b450132
213269sildenafil 25 MG Oral Tablet [Viagra]SBD0b0be196-0c62-461c-94f4-9a35339b450132
213270sildenafil 50 MG Oral Tablet [Viagra]SBD0b0be196-0c62-461c-94f4-9a35339b450132
314229sildenafil 100 MG Oral TabletSCD0b0be196-0c62-461c-94f4-9a35339b450132
314228sildenafil 25 MG Oral TabletSCD0b0be196-0c62-461c-94f4-9a35339b450132
312950sildenafil 50 MG Oral TabletSCD0b0be196-0c62-461c-94f4-9a35339b450132
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
213271Viagra 100 MG (as sildenafil citrate) Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
213271Viagra 100 MG Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
213269Viagra 25 MG (as sildenafil citrate) Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
213269Viagra 25 MG Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
213270Viagra 50 MG (as sildenafil citrate) Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
213270Viagra 50 MG Oral TabletSY0b0be196-0c62-461c-94f4-9a35339b450132
314229sildenafil citrate 100 MG Oral TabletPSNc6c048ec-0b99-4fa4-9df7-9926db93749b4
314228sildenafil citrate 25 MG Oral TabletPSNc6c048ec-0b99-4fa4-9df7-9926db93749b4
312950sildenafil citrate 50 MG Oral TabletPSNc6c048ec-0b99-4fa4-9df7-9926db93749b4
213271Viagra 100 MG Oral TabletPSNc6c048ec-0b99-4fa4-9df7-9926db93749b4
213269Viagra 25 MG Oral TabletPSNc6c048ec-0b99-4fa4-9df7-9926db93749b4
213270Viagra 50 MG Oral TabletPSNc6c048ec-0b99-4fa4-9df7-9926db93749b4
213271sildenafil 100 MG Oral Tablet [Viagra]SBDc6c048ec-0b99-4fa4-9df7-9926db93749b4
213269sildenafil 25 MG Oral Tablet [Viagra]SBDc6c048ec-0b99-4fa4-9df7-9926db93749b4
213270sildenafil 50 MG Oral Tablet [Viagra]SBDc6c048ec-0b99-4fa4-9df7-9926db93749b4
314229sildenafil 100 MG Oral TabletSCDc6c048ec-0b99-4fa4-9df7-9926db93749b4
314228sildenafil 25 MG Oral TabletSCDc6c048ec-0b99-4fa4-9df7-9926db93749b4
312950sildenafil 50 MG Oral TabletSCDc6c048ec-0b99-4fa4-9df7-9926db93749b4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
213271Viagra 100 MG (as sildenafil citrate) Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
213271Viagra 100 MG Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
213269Viagra 25 MG (as sildenafil citrate) Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
213269Viagra 25 MG Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
213270Viagra 50 MG (as sildenafil citrate) Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
213270Viagra 50 MG Oral TabletSYc6c048ec-0b99-4fa4-9df7-9926db93749b4
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
0069-4200-300006942003030 TABLET, FILM COATED in 1 BOTTLE (0069-4200-30) 1998-03-272027-09-30NoNoCurrent