FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
50436-0035
11-digit product format
504360035
Labeler code
50436
Product ID
50436-0035_8a240812-6508-4efa-8335-eb1be7af89e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
NDA020895
Marketing category
NDA
Marketing start
2017-12-01
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
50 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
50436-0035-12021-01-29C16284748780-1ba0f9c33-52d9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SILDENAFIL CITRATE TABLETS safely and effectively. See full prescribing information for SILDENAFIL CITRATE TABLETS. SILDENAFIL CITRATE TABLETS (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0035-1Sildenafil Citrate1 in 1 POUCHTABLET, FILM COATED14
50436-0035-1Sildenafil Citrate200 in 1 CASETABLET, FILM COATED2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0035SILDENAFIL CITRATE TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 2 package rows20191120_7c3798c1-7884-4943-a59e-079524e12512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil citrate 50 MG Oral TabletPSN7c3798c1-7884-4943-a59e-079524e125124
314229sildenafil 100 MG Oral TabletSCD7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil 50 MG Oral TabletSCD7c3798c1-7884-4943-a59e-079524e125124
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY7c3798c1-7884-4943-a59e-079524e125124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0035-1504360035011 in 1 POUCHHistorical