Sildenafil

Product NDC
50268-717
11-digit product format
502680717
Labeler code
50268
Product ID
50268-717_436cc2bc-6fb4-227a-e063-6294a90ae221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA202025
Marketing category
ANDA
Marketing start
2015-05-29
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
BW9B0ZE037SILDENAFIL CITRATE171599-83-0SILDENAFIL CITRATE
3M7OB98Y7HSILDENAFIL139755-83-2Sildenafil

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-717-155026807171550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-717-15) / 1 TABLET in 1 BLISTER PACK (50268-717-11) 50 blister pack2015-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilAvPAK2025-11-12HUMAN PRESCRIPTION DRUG LABEL6
SildenafilAvPAK2024-01-08HUMAN PRESCRIPTION DRUG LABEL5