Sildenafil

Product NDC
68071-2985
11-digit product format
680712985
Labeler code
68071
Product ID
68071-2985_2dcdd45a-556b-0b9f-e063-6394a90a8a3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202023
Marketing category
ANDA
Marketing start
2018-06-28
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
68071-2985-36807129850330 TABLET, FILM COATED in 1 BOTTLE (68071-2985-3) 2023-04-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilNuCare Pharmaceuticals,Inc.2025-02-10HUMAN PRESCRIPTION DRUG LABEL2