FDA.reportPublic FDA data

Sildenafil

Product NDC
68788-7218
11-digit product format
687887218
Labeler code
68788
Product ID
68788-7218_2679593b-243b-42cd-9df8-09611c35bb3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-07-26
Marketing end
0000-00-00
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
2020-12-31
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
68788-7218-32021-01-29C16284748780-1ba0f9c33-2f91-a910-e053-dadaa90a0b85These 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
68788-7218-42021-01-29C16284748780-1ba0f9c33-2f91-a910-e053-dadaa90a0b85These 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
68788-7218-62021-01-29C16284748780-1ba0f9c33-2f91-a910-e053-dadaa90a0b85These 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
68788-7218-72021-01-29C16284748780-1ba0f9c33-2f91-a910-e053-dadaa90a0b85These 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
68788-7218-92021-01-29C16284748780-1ba0f9c33-2f91-a910-e053-dadaa90a0b85These 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
68788-7218-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED302
68788-7218-4Sildenafil4 in 1 BOTTLETABLET, FILM COATED42
68788-7218-6Sildenafil60 in 1 BOTTLETABLET, FILM COATED602
68788-7218-7Sildenafil7 in 1 BOTTLETABLET, FILM COATED72
68788-7218-9Sildenafil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7218SILDENAFIL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Legacy NDC, 5 package rows20190323_0720268c-2c92-4632-8c55-76c254d1beb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil 100 MG Oral TabletSCD0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0720268c-2c92-4632-8c55-76c254d1beb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-7218-36878872180330 in 1 BOTTLEHistorical
68788-7218-4687887218044 in 1 BOTTLEHistorical
68788-7218-66878872180660 in 1 BOTTLEHistorical
68788-7218-7687887218077 in 1 BOTTLEHistorical
68788-7218-96878872180990 in 1 BOTTLEHistorical