FDA.reportPublic FDA data

Sildenafil

Product NDC
50268-717
11-digit product format
502680717
Labeler code
50268
Product ID
50268-717_436cc2bc-6fb4-227a-e063-6294a90ae221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA202025
Marketing category
ANDA
Marketing start
2015-05-29
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
50268-717-11Sildenafil1 in 1 BLISTER PACKTABLET16
50268-717-15Sildenafil50 in 1 BOX, UNIT-DOSETABLET506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-717-11EA - Each50268-717fba4de66-2aa2-4cc6-886e-c2c6896add8b12015-07-20
50268-717-15EA - Each50268-7173e90a8b5-0511-4618-80f0-ad2d5b1f1f8212015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
TALCINACTIVE INGREDIENT7SEV7J4R1USILDENAFIL (SILDENAFIL) TABLET [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL (SILDENAFIL) TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-717SILDENAFIL TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_e08de794-9b7e-aae6-9c89-a0c0d090cc76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNe08de794-9b7e-aae6-9c89-a0c0d090cc766
577033sildenafil 20 MG Oral TabletSCDe08de794-9b7e-aae6-9c89-a0c0d090cc766
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe08de794-9b7e-aae6-9c89-a0c0d090cc766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-717-11502680717111 in 1 BLISTER PACKHistorical
50268-717-155026807171550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-717-15) / 1 TABLET in 1 BLISTER PACK (50268-717-11) 50 blister pack2015-05-290000-00-00NoNoCurrent