Sildenafil

Product NDC
68071-3908
11-digit product format
680713908
Labeler code
68071
Product ID
68071-3908_41b2c18b-9ec3-4dae-e063-6294a90a8923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
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
68071-3908-16807139080110 TABLET, FILM COATED in 1 BOTTLE (68071-3908-1) 2025-10-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilNuCare Pharmaceuticals,Inc.2025-10-21HUMAN PRESCRIPTION DRUG LABEL1