Sildenafil

Product NDC
68788-7879
11-digit product format
687887879
Labeler code
68788
Product ID
68788-7879_be069c7b-77d7-4eee-b686-969fd72b8d84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2021-03-08
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-7879-16878878790110 TABLET, FILM COATED in 1 BOTTLE (68788-7879-1) 2021-03-08NoNoHistorical
68788-7879-7687887879077 TABLET, FILM COATED in 1 BOTTLE (68788-7879-7) 2021-03-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilPreferred Pharmaceuticals, Inc.2025-09-22HUMAN PRESCRIPTION DRUG LABEL5