FDA.reportPublic FDA data

Sildenafil

Product NDC
50436-5517
11-digit product format
504365517
Labeler code
50436
Product ID
50436-5517_39a7d9c5-7fd4-4e14-9a2c-1627c66d8e00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
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
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
50436-5517-12021-01-29C16284748780-1ba0f9c33-0ead-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
50436-5517-22021-01-29C16284748780-1ba0f9c33-0ead-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
50436-5517-32021-01-29C16284748780-1ba0f9c33-0ead-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
50436-5517-1Sildenafil3 in 1 POUCHTABLET, FILM COATED32
50436-5517-1Sildenafil200 in 1 CASETABLET, FILM COATED2002
50436-5517-2Sildenafil200 in 1 CASETABLET, FILM COATED2002
50436-5517-2Sildenafil4 in 1 POUCHTABLET, FILM COATED42
50436-5517-3Sildenafil5 in 1 POUCHTABLET, FILM COATED52
50436-5517-3Sildenafil200 in 1 CASETABLET, FILM COATED2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-5517SILDENAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 6 package rows20181027_6512178a-7358-4c2c-a341-b888f5433883.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN6512178a-7358-4c2c-a341-b888f54338832
577033sildenafil 20 MG Oral TabletSCD6512178a-7358-4c2c-a341-b888f54338832
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY6512178a-7358-4c2c-a341-b888f54338832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-5517-1504365517013 in 1 POUCHHistorical
50436-5517-250436551702200 in 1 CASEHistorical
50436-5517-3504365517035 in 1 POUCHHistorical