FDA.reportPublic FDA data

Sildenafil

Product NDC
50436-0034
11-digit product format
504360034
Labeler code
50436
Product ID
50436-0034_c92d4efd-8bbc-4d84-b952-22f6b246ab02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
NDA021845
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-27
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
2023-12-31
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
50436-0034-12024-01-30C16284748780-11030e365-1822-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Sildenafil for oral suspension Initial U.S. Approval: 1998
50436-0034-22024-01-30C16284748780-11030e365-1822-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Sildenafil for oral suspension Initial U.S. Approval: 1998
50436-0034-32024-01-30C16284748780-11030e365-1822-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Sildenafil for oral suspension Initial U.S. Approval: 1998
50436-0034-42024-01-30C16284748780-11030e365-1822-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Sildenafil for oral suspension Initial U.S. Approval: 1998
50436-0034-52024-01-30C16284748780-11030e365-1822-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use sildenafil safely and effectively. See full prescribing information for sildenafil. Sildenafil tablets, for oral use Sildenafil for oral suspension Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0034-1Sildenafil1 in 1 POUCHTABLET, FILM COATED12
50436-0034-2Sildenafil2 in 1 POUCHTABLET, FILM COATED22
50436-0034-3Sildenafil3 in 1 POUCHTABLET, FILM COATED32
50436-0034-4Sildenafil4 in 1 POUCHTABLET, FILM COATED42
50436-0034-5Sildenafil5 in 1 POUCHTABLET, FILM COATED52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0034SILDENAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 5 package rows20220315_e1164415-0fe0-409f-b2b2-5c34bc36b51a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNe1164415-0fe0-409f-b2b2-5c34bc36b51a2
577033sildenafil 20 MG Oral TabletSCDe1164415-0fe0-409f-b2b2-5c34bc36b51a2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe1164415-0fe0-409f-b2b2-5c34bc36b51a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0034-1504360034011 TABLET, FILM COATED in 1 POUCH (50436-0034-1) 2022-03-010000-00-00NoNoCurrent
50436-0034-2504360034022 TABLET, FILM COATED in 1 POUCH (50436-0034-2) 2022-03-010000-00-00NoNoCurrent
50436-0034-3504360034033 TABLET, FILM COATED in 1 POUCH (50436-0034-3) 2022-03-010000-00-00NoNoCurrent
50436-0034-4504360034044 TABLET, FILM COATED in 1 POUCH (50436-0034-4) 2022-03-010000-00-00NoNoCurrent
50436-0034-5504360034055 TABLET, FILM COATED in 1 POUCH (50436-0034-5) 2022-03-010000-00-00NoNoCurrent