Sildenafil

Product NDC
82804-243
11-digit product format
828040243
Labeler code
82804
Product ID
82804-243_71140bd5-0a51-4c01-ad0d-193d08ea67dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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 formatDescriptionMarketing startSampleExclude flagStatus
82804-243-308280402433030 TABLET, FILM COATED in 1 BOTTLE (82804-243-30) 2025-09-10NoNoHistorical
82804-243-908280402439090 TABLET, FILM COATED in 1 BOTTLE (82804-243-90) 2025-09-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilProficient Rx LP2025-09-01HUMAN PRESCRIPTION DRUG LABEL1