Sildenafil

Product NDC
63629-5029
11-digit product format
636295029
Labeler code
63629
Product ID
63629-5029_9b2a355b-6ad7-44e7-97a0-9cc736fa479e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202025
Marketing category
ANDA
Marketing start
2012-11-08
Substance
SILDENAFIL CITRATE
Active strength
20 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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-5029-06362950290050 TABLET in 1 BOTTLE (63629-5029-0) 50 tablet2024-04-02NoNoHistorical
63629-5029-16362950290110 TABLET in 1 BOTTLE (63629-5029-1) 10 tablet2013-08-21NoNoHistorical
63629-5029-26362950290230 TABLET in 1 BOTTLE (63629-5029-2) 30 tablet2013-06-06NoNoHistorical
63629-5029-3636295029037 TABLET in 1 BOTTLE (63629-5029-3) 7 tablet2013-08-02NoNoHistorical
63629-5029-46362950290490 TABLET in 1 BOTTLE (63629-5029-4) 90 tablet2014-05-08NoNoHistorical
63629-5029-56362950290560 TABLET in 1 BOTTLE (63629-5029-5) 60 tablet2018-03-28NoNoHistorical
63629-5029-66362950290620 TABLET in 1 BOTTLE (63629-5029-6) 20 tablet2016-03-24NoNoHistorical
63629-5029-763629502907270 TABLET in 1 BOTTLE (63629-5029-7) 270 tablet2024-04-02NoNoHistorical
63629-5029-86362950290815 TABLET in 1 BOTTLE (63629-5029-8) 15 tablet2024-04-02NoNoHistorical
63629-5029-96362950290912 TABLET in 1 BOTTLE (63629-5029-9) 12 tablet2017-10-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SildenafilBryant Ranch Prepack2024-04-02HUMAN PRESCRIPTION DRUG LABEL1003