VARDENAFIL HYDROCHLORIDE

Product NDC
62332-236
11-digit product format
623320236
Labeler code
62332
Product ID
62332-236_fb17a719-cf8a-4d04-885a-3908378c5216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214031
Marketing category
ANDA
Marketing start
2020-08-05
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
2.5 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
62332-236-306233202363030 TABLET, FILM COATED in 1 BOTTLE (62332-236-30) 2020-08-05NoNoHistorical
62332-236-3162332023631100 TABLET, FILM COATED in 1 BOTTLE (62332-236-31) 2020-08-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
VARDENAFIL HYDROCHLORIDEAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2023-03-22Human Prescription Drug Label8