FDA.reportPublic FDA data

Sildenafil

Product NDC
65162-351
11-digit product format
651620351
Labeler code
65162
Product ID
65162-351_fcdd909b-5c4f-4055-8a2a-61c672d68994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA202025
Marketing category
ANDA
Marketing start
2012-11-08
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-351-09Sildenafil90 in 1 BOTTLETABLET9020
65162-351-11Sildenafil1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-351-09EA - Each65162-351b665a37a-3695-4194-99c5-c14054fb8a2512013-04-01
65162-351-11EA - Each65162-35143fd84cf-a770-47bf-b340-7f1f1efa93a012022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFILACTIVE INGREDIENT3M7OB98Y7HSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1USILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET [BRYANT RANCH PREPACK]1000
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
TALCINACTIVE INGREDIENT7SEV7J4R1USILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]12
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
65162-351SILDENAFIL TABLET [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 2 package rows20250207_187de471-3e79-44ed-b560-0f8b2d549f74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNa636d3c7-af25-4148-8b4e-6f44deba700b1003
577033sildenafil 20 MG Oral TabletSCDa636d3c7-af25-4148-8b4e-6f44deba700b1003
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa636d3c7-af25-4148-8b4e-6f44deba700b1003
577033sildenafil citrate 20 MG Oral TabletPSN187de471-3e79-44ed-b560-0f8b2d549f7420
577033sildenafil 20 MG Oral TabletSCD187de471-3e79-44ed-b560-0f8b2d549f7420
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY187de471-3e79-44ed-b560-0f8b2d549f7420
577033sildenafil citrate 20 MG Oral TabletPSN38a5592a-c14a-40af-a19a-588cb11090ed6
577033sildenafil citrate 20 MG Oral TabletPSNe08de794-9b7e-aae6-9c89-a0c0d090cc766
577033sildenafil 20 MG Oral TabletSCDe08de794-9b7e-aae6-9c89-a0c0d090cc766
577033sildenafil 20 MG Oral TabletSCD38a5592a-c14a-40af-a19a-588cb11090ed6
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY38a5592a-c14a-40af-a19a-588cb11090ed6
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe08de794-9b7e-aae6-9c89-a0c0d090cc766
577033sildenafil citrate 20 MG Oral TabletPSNfa14cb6b-0fa8-0ba0-e053-6294a90afae33
577033sildenafil 20 MG Oral TabletSCDfa14cb6b-0fa8-0ba0-e053-6294a90afae33
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYfa14cb6b-0fa8-0ba0-e053-6294a90afae33
577033sildenafil citrate 20 MG Oral TabletPSNf5113b5e-9087-4397-86bc-5ea10413c4291
577033sildenafil 20 MG Oral TabletSCDf5113b5e-9087-4397-86bc-5ea10413c4291
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf5113b5e-9087-4397-86bc-5ea10413c4291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-351-096516203510990 TABLET in 1 BOTTLE (65162-351-09) 90 tablet2012-11-080000-00-00NoNoCurrent
65162-351-11651620351111000 TABLET in 1 BOTTLE (65162-351-11) 1000 tablet2012-11-080000-00-00NoNoCurrent