Sildenafil Citrate

Product NDC
82804-025
11-digit product format
828040025
Labeler code
82804
Product ID
82804-025_b9b1d6ee-da42-4ef2-ab93-cd36d7f34150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206401
Marketing category
ANDA
Marketing start
2018-10-12
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
82804-025-308280400253030 TABLET, FILM COATED in 1 BOTTLE (82804-025-30) 2023-10-12NoNoHistorical
82804-025-608280400256060 TABLET, FILM COATED in 1 BOTTLE (82804-025-60) 2023-10-12NoNoHistorical
82804-025-908280400259090 TABLET, FILM COATED in 1 BOTTLE (82804-025-90) 2023-10-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sildenafil CitrateProficient Rx LP2023-10-01HUMAN PRESCRIPTION DRUG LABEL1