Sildenafil

Product NDC
68071-3743
11-digit product format
680713743
Labeler code
68071
Product ID
68071-3743_28f2a326-e32e-adf1-e063-6294a90aa7fc
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
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
3M7OB98Y7HSILDENAFIL139755-83-2Sildenafil

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3743-36807137430330 TABLET, FILM COATED in 1 BOTTLE (68071-3743-3) 2024-12-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilNuCare Pharmaceuticals, Inc.2024-12-10HUMAN PRESCRIPTION DRUG LABEL1