Sildenafil

Product NDC
68071-5115
11-digit product format
680715115
Labeler code
68071
Product ID
68071-5115_1b46e585-2279-d1f6-e063-6294a90a0749
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
Marketing end
2027-10-31
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
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 startMarketing endSampleExclude flagStatus
68071-5115-66807151150660 TABLET, FILM COATED in 1 BOTTLE (68071-5115-6) 2014-01-032027-10-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilNuCare Pharmaceuticals,Inc.2024-06-19HUMAN PRESCRIPTION DRUG LABEL3