FDA.reportPublic FDA data

Sildenafil

Product NDC
68788-7379
11-digit product format
687887379
Labeler code
68788
Product ID
68788-7379_2eb90f6c-a5de-472a-98eb-cdc027e74e2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202503
Marketing category
ANDA
Marketing start
2016-08-25
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
20 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7379-32020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
68788-7379-42020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
68788-7379-62020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
68788-7379-92020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7379-3Sildenafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68788-7379-4Sildenafil4 in 1 BOTTLE, PLASTICTABLET, FILM COATED41
68788-7379-6Sildenafil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-7379-9Sildenafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7379SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Legacy NDC, 4 package rows20160826_2eb90f6c-a5de-472a-98eb-cdc027e74e2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN2eb90f6c-a5de-472a-98eb-cdc027e74e2e1
577033sildenafil 20 MG Oral TabletSCD2eb90f6c-a5de-472a-98eb-cdc027e74e2e1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY2eb90f6c-a5de-472a-98eb-cdc027e74e2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-7379-36878873790330 in 1 BOTTLE, PLASTICHistorical
68788-7379-4687887379044 in 1 BOTTLE, PLASTICHistorical
68788-7379-66878873790660 in 1 BOTTLE, PLASTICHistorical
68788-7379-96878873790990 in 1 BOTTLE, PLASTICHistorical