FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
50436-0295
11-digit product format
504360295
Labeler code
50436
Product ID
50436-0295_ba21a03e-5123-4e8f-a35e-1114e7324e87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA204883
Marketing category
ANDA
Marketing start
2019-01-01
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
50436-0295-12021-01-29C16284748780-1ba0f9c33-1101-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
50436-0295-22021-01-29C16284748780-1ba0f9c33-1101-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
50436-0295-32021-01-29C16284748780-1ba0f9c33-1101-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
50436-0295-42021-01-29C16284748780-1ba0f9c33-1101-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
50436-0295-52021-01-29C16284748780-1ba0f9c33-1101-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
50436-0295-1Sildenafil Citrate1 in 1 POUCHTABLET, FILM COATED13
50436-0295-1Sildenafil Citrate200 in 1 CASETABLET, FILM COATED2003
50436-0295-2Sildenafil Citrate200 in 1 CASETABLET, FILM COATED2003
50436-0295-2Sildenafil Citrate2 in 1 POUCHTABLET, FILM COATED23
50436-0295-3Sildenafil Citrate3 in 1 POUCHTABLET, FILM COATED33
50436-0295-3Sildenafil Citrate200 in 1 CASETABLET, FILM COATED2003
50436-0295-4Sildenafil Citrate200 in 1 CASETABLET, FILM COATED2003
50436-0295-4Sildenafil Citrate4 in 1 POUCHTABLET, FILM COATED43
50436-0295-5Sildenafil Citrate200 in 1 CASETABLET, FILM COATED2003
50436-0295-5Sildenafil Citrate5 in 1 POUCHTABLET, FILM COATED53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0295SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [UNIT DOSE SERVICES]3Legacy NDC, 10 package rows20190320_479fb45a-ae9d-40a5-bcf4-34ec55ecdacd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil 20 MG Oral TabletSCD479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0295-1504360295011 in 1 POUCHHistorical
50436-0295-250436029502200 in 1 CASEHistorical
50436-0295-3504360295033 in 1 POUCHHistorical
50436-0295-450436029504200 in 1 CASEHistorical
50436-0295-550436029505200 in 1 CASEHistorical