FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
50436-0185
11-digit product format
504360185
Labeler code
50436
Product ID
50436-0185_32b61922-a419-46ca-b466-eae33c01fbec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0185-12021-01-29C16284748780-1ba0f9c33-4212-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
50436-0185-22021-01-29C16284748780-1ba0f9c33-4212-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
50436-0185-32021-01-29C16284748780-1ba0f9c33-4212-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
50436-0185-1SILDENAFIL CITRATE3 in 1 POUCHTABLET32
50436-0185-1SILDENAFIL CITRATE200 in 1 CASETABLET2002
50436-0185-2SILDENAFIL CITRATE4 in 1 POUCHTABLET42
50436-0185-2SILDENAFIL CITRATE200 in 1 CASETABLET2002
50436-0185-3SILDENAFIL CITRATE5 in 1 POUCHTABLET52
50436-0185-3SILDENAFIL CITRATE200 in 1 CASETABLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0185SILDENAFIL CITRATE TABLET [UNIT DOSE SERVICES]2Legacy NDC, 6 package rows20181027_a9599ede-632f-436b-9b74-feb98e77ff1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG Oral TabletSCDa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa9599ede-632f-436b-9b74-feb98e77ff1b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0185-1504360185013 in 1 POUCHHistorical
50436-0185-2504360185024 in 1 POUCHHistorical
50436-0185-3504360185035 in 1 POUCHHistorical