FDA.reportPublic FDA data

Sildenafil

Product NDC
50436-9121
11-digit product format
504369121
Labeler code
50436
Product ID
50436-9121_a29f2c12-6cec-44ec-898e-cf79dafabb55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
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
50436-9121-12024-01-30C16284748780-11030e365-03a8-111a-e063-dadaa90a10e2These 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
50436-9121-22024-01-30C16284748780-11030e365-03a8-111a-e063-dadaa90a10e2These 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
50436-9121-32024-01-30C16284748780-11030e365-03a8-111a-e063-dadaa90a10e2These 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
50436-9121-42024-01-30C16284748780-11030e365-03a8-111a-e063-dadaa90a10e2These 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
50436-9121-1Sildenafil36 in 1 BOTTLETABLET, FILM COATED364
50436-9121-2Sildenafil108 in 1 BOTTLETABLET, FILM COATED1084
50436-9121-3Sildenafil54 in 1 BOTTLETABLET, FILM COATED544
50436-9121-4Sildenafil81 in 1 BOTTLETABLET, FILM COATED814

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9121SILDENAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20220922_0a9ec226-572a-47f1-aea1-514615b2b6ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN0a9ec226-572a-47f1-aea1-514615b2b6ed4
577033sildenafil 20 MG Oral TabletSCD0a9ec226-572a-47f1-aea1-514615b2b6ed4
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY0a9ec226-572a-47f1-aea1-514615b2b6ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-9121-15043691210136 TABLET, FILM COATED in 1 BOTTLE (50436-9121-1) 2022-08-010000-00-00NoNoCurrent
50436-9121-250436912102108 TABLET, FILM COATED in 1 BOTTLE (50436-9121-2) 2022-08-010000-00-00NoNoCurrent
50436-9121-35043691210354 TABLET, FILM COATED in 1 BOTTLE (50436-9121-3) 2022-09-010000-00-00NoNoCurrent
50436-9121-45043691210481 TABLET, FILM COATED in 1 BOTTLE (50436-9121-4) 2022-09-010000-00-00NoNoCurrent