FDA.reportPublic FDA data

SILDENAFIL

Product NDC
52817-342
11-digit product format
528170342
Labeler code
52817
Product ID
52817-342_294da798-e782-4269-e063-6394a90a4b35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA204882
Marketing category
ANDA
Marketing start
2018-07-01
Substance
SILDENAFIL CITRATE
Active strength
100 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 314229

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-342-10SILDENAFIL100 in 1 BOTTLETABLET, FILM COATED1003
52817-342-30SILDENAFIL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-342-30EA - Each52817-3426672423f-a6ba-4fd6-8e9b-89f1b37ddd6a12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-342SILDENAFIL TABLET, FILM COATED [TRUPHARMA LLC]3Current NDC, Legacy NDC, 2 package rows20241217_53078688-ad66-4bb2-808c-b76acedd00e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN53078688-ad66-4bb2-808c-b76acedd00e33
314228sildenafil citrate 25 MG Oral TabletPSN53078688-ad66-4bb2-808c-b76acedd00e33
312950sildenafil citrate 50 MG Oral TabletPSN53078688-ad66-4bb2-808c-b76acedd00e33
314229sildenafil 100 MG Oral TabletSCD53078688-ad66-4bb2-808c-b76acedd00e33
314228sildenafil 25 MG Oral TabletSCD53078688-ad66-4bb2-808c-b76acedd00e33
312950sildenafil 50 MG Oral TabletSCD53078688-ad66-4bb2-808c-b76acedd00e33
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY53078688-ad66-4bb2-808c-b76acedd00e33
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY53078688-ad66-4bb2-808c-b76acedd00e33
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY53078688-ad66-4bb2-808c-b76acedd00e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-342-1052817034210100 TABLET, FILM COATED in 1 BOTTLE (52817-342-10) 2018-07-010000-00-00NoNoCurrent
52817-342-305281703423030 TABLET, FILM COATED in 1 BOTTLE (52817-342-30) 2018-07-010000-00-00NoNoCurrent