FDA.reportPublic FDA data

Viagra

Product NDC
21695-157
11-digit product format
216950157
Labeler code
21695
Product ID
21695-157_4d60822d-1c9b-494d-adb3-20fe921d9c58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020895
Marketing category
NDA
Marketing start
2003-07-17
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
E
Listing certified through
2017-12-31
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
21695-157-152019-09-24C16284748780-1934fe258-4b54-48b1-e053-8cdaa90a720aViagra
21695-157-302019-09-24C16284748780-1934fe258-4b54-48b1-e053-8cdaa90a720aViagra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-157-15Viagra15 in 1 BOTTLETABLET, FILM COATED151
21695-157-30Viagra30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-157-15EA - Each21695-1576f630fe3-05f6-42be-b228-6f558487627812012-07-24
21695-157-30EA - Each21695-15796e8e99c-3156-4209-ae6b-ef6c277ebb9412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILDENAFILACTIVE MOIETY3M7OB98Y7HVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-157VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_4d60822d-1c9b-494d-adb3-20fe921d9c58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN4d60822d-1c9b-494d-adb3-20fe921d9c581
312950sildenafil citrate 50 MG Oral TabletPSN4d60822d-1c9b-494d-adb3-20fe921d9c581
213271Viagra 100 MG Oral TabletPSN4d60822d-1c9b-494d-adb3-20fe921d9c581
213270Viagra 50 MG Oral TabletPSN4d60822d-1c9b-494d-adb3-20fe921d9c581
213271sildenafil 100 MG Oral Tablet [Viagra]SBD4d60822d-1c9b-494d-adb3-20fe921d9c581
213270sildenafil 50 MG Oral Tablet [Viagra]SBD4d60822d-1c9b-494d-adb3-20fe921d9c581
314229sildenafil 100 MG Oral TabletSCD4d60822d-1c9b-494d-adb3-20fe921d9c581
312950sildenafil 50 MG Oral TabletSCD4d60822d-1c9b-494d-adb3-20fe921d9c581
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY4d60822d-1c9b-494d-adb3-20fe921d9c581
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY4d60822d-1c9b-494d-adb3-20fe921d9c581
213271Viagra 100 MG (as sildenafil citrate) Oral TabletSY4d60822d-1c9b-494d-adb3-20fe921d9c581
213271Viagra 100 MG Oral TabletSY4d60822d-1c9b-494d-adb3-20fe921d9c581
213270Viagra 50 MG (as sildenafil citrate) Oral TabletSY4d60822d-1c9b-494d-adb3-20fe921d9c581
213270Viagra 50 MG Oral TabletSY4d60822d-1c9b-494d-adb3-20fe921d9c581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-157-152169501571515 in 1 BOTTLEHistorical
21695-157-302169501573030 in 1 BOTTLEHistorical