Vardenafil Hydrochloride

Product NDC
71335-9688
11-digit product format
713359688
Labeler code
71335
Product ID
71335-9688_5b030c96-c5e2-4cde-abda-d6eedff4169d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091347
Marketing category
ANDA
Marketing start
2019-01-03
Substance
VARDENAFIL HYDROCHLORIDE
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
5M8S2CU0TSVARDENAFIL HYDROCHLORIDE330808-88-3VARDENAFIL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9688-17133596880130 TABLET, FILM COATED in 1 BOTTLE (71335-9688-1) 2024-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Vardenafil HydrochlorideBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL101