Sildenafil Citrate

Product NDC
45865-937
11-digit product format
458650937
Labeler code
45865
Product ID
45865-937_7df35d1d-0eea-4933-e053-2991aa0ace33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA091448
Marketing category
ANDA
Marketing start
2017-12-11
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
100 1/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-937-30Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-937SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181227_7df35d1d-0ee9-4933-e053-2991aa0ace33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN7df35d1d-0ee9-4933-e053-2991aa0ace331
314229sildenafil 100 MG Oral TabletSCD7df35d1d-0ee9-4933-e053-2991aa0ace331
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY7df35d1d-0ee9-4933-e053-2991aa0ace331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-937-304586509373030 in 1 BOTTLEHistorical