SILDENAFIL CITRATE

Product NDC
72789-405
11-digit product format
727890405
Labeler code
72789
Product ID
72789-405_31f6c2bb-9a5b-e2f0-e063-6294a90aace5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2020-09-04
Substance
SILDENAFIL CITRATE
Active strength
50 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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-405-157278904051515 TABLET in 1 BOTTLE, PLASTIC (72789-405-15) 15 tablet2024-06-07NoNoHistorical
72789-405-307278904053030 TABLET in 1 BOTTLE, PLASTIC (72789-405-30) 30 tablet2024-06-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.2025-04-04HUMAN PRESCRIPTION DRUG LABEL12