FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1088
11-digit product format
713351088
Labeler code
71335
Product ID
71335-1088_68a2f6ec-89ff-4d93-abcd-78cae066ee54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202659
Marketing category
ANDA
Marketing start
2018-06-11
Substance
SILDENAFIL CITRATE
Active strength
100 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 CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
71335-1088-0Sildenafil15 in 1 BOTTLETABLET, FILM COATED15105
71335-1088-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED10105
71335-1088-2Sildenafil5 in 1 BOTTLETABLET, FILM COATED5105
71335-1088-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED30105
71335-1088-4Sildenafil2 in 1 BOTTLETABLET, FILM COATED2105
71335-1088-5Sildenafil6 in 1 BOTTLETABLET, FILM COATED6105
71335-1088-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED20105
71335-1088-7Sildenafil4 in 1 BOTTLETABLET, FILM COATED4105
71335-1088-8Sildenafil90 in 1 BOTTLETABLET, FILM COATED90105
71335-1088-9Sildenafil60 in 1 BOTTLETABLET, FILM COATED60105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1088-0EA - Each71335-1088faa80ca9-af84-4447-844b-7a9023cdb5bd12022-06-06
71335-1088-1EA - Each71335-1088e3e8fccb-45e3-492d-abd8-3aeca97499e812022-06-06
71335-1088-2EA - Each71335-1088625b40e6-5e5c-41ed-aad9-14ede4ec538812022-06-06
71335-1088-3EA - Each71335-10880c937e4b-90e9-44dd-964d-7f952142012912022-06-06
71335-1088-4EA - Each71335-1088019328c7-ce8a-4252-8b2f-974cd577e8ab12022-06-06
71335-1088-6EA - Each71335-1088469282e6-387c-436b-97f3-574954c5cada12022-06-06
71335-1088-8EA - Each71335-1088e718c255-f2a5-42c2-a13b-c0d2868fcc2012022-06-06
71335-1088-9EA - Each71335-10886c44b3a9-f5ca-4a99-8d27-af38f39abcb312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1088SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240823_f66ce83b-bad6-4180-a8c4-8475a8ec50b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf66ce83b-bad6-4180-a8c4-8475a8ec50b7105
314229sildenafil 100 MG Oral TabletSCDf66ce83b-bad6-4180-a8c4-8475a8ec50b7105
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf66ce83b-bad6-4180-a8c4-8475a8ec50b7105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1088-07133510880015 TABLET, FILM COATED in 1 BOTTLE (71335-1088-0) 2022-02-090000-00-00NoNoCurrent
71335-1088-17133510880110 TABLET, FILM COATED in 1 BOTTLE (71335-1088-1) 2022-02-090000-00-00NoNoCurrent
71335-1088-2713351088025 TABLET, FILM COATED in 1 BOTTLE (71335-1088-2) 2022-02-090000-00-00NoNoCurrent
71335-1088-37133510880330 TABLET, FILM COATED in 1 BOTTLE (71335-1088-3) 2022-02-090000-00-00NoNoCurrent
71335-1088-4713351088042 TABLET, FILM COATED in 1 BOTTLE (71335-1088-4) 2022-02-090000-00-00NoNoCurrent
71335-1088-5713351088056 TABLET, FILM COATED in 1 BOTTLE (71335-1088-5) 2022-02-090000-00-00NoNoCurrent
71335-1088-67133510880620 TABLET, FILM COATED in 1 BOTTLE (71335-1088-6) 2022-02-090000-00-00NoNoCurrent
71335-1088-7713351088074 TABLET, FILM COATED in 1 BOTTLE (71335-1088-7) 2022-02-090000-00-00NoNoCurrent
71335-1088-87133510880890 TABLET, FILM COATED in 1 BOTTLE (71335-1088-8) 2022-02-090000-00-00NoNoCurrent
71335-1088-97133510880960 TABLET, FILM COATED in 1 BOTTLE (71335-1088-9) 2022-02-090000-00-00NoNoCurrent