FDA.reportPublic FDA data

Sildenafil

Product NDC
53002-1719
11-digit product format
530021719
Labeler code
53002
Product ID
53002-1719_69623a01-204b-4806-8992-5712e5aa25ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078380
Marketing category
ANDA
Marketing start
2013-05-31
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
No
Listing certified through
2021-12-31
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
53002-1719-32025-01-30C16284748780-19d75b9d0-9148-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
53002-1719-32023-06-07C16284748780-19d75b9d0-9148-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
53002-1719-32023-01-30C16284748780-19d75b9d0-9148-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
53002-1719-32020-12-16C16284748780-19d75b9d0-9148-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
53002-1719-32020-01-31C16284748780-19d75b9d0-9148-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
53002-1719-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1719SILDENAFIL TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_3a334046-c27d-4480-be3f-6ce1445abcc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN3a334046-c27d-4480-be3f-6ce1445abcc45
577033sildenafil 20 MG Oral TabletSCD3a334046-c27d-4480-be3f-6ce1445abcc45
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY3a334046-c27d-4480-be3f-6ce1445abcc45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1719-35300217190330 TABLET, FILM COATED in 1 BOTTLE (53002-1719-3) 2018-10-010000-00-00NoNoCurrent