VARDENAFIL HYDROCHLORIDE

Product NDC
71335-2357
11-digit product format
713352357
Labeler code
71335
Product ID
71335-2357_d372a596-aa3a-4bd7-b311-ee32b051d758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214031
Marketing category
ANDA
Marketing start
2020-08-05
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

Additional Listing Data#

Finished product
Yes
Brand name base
VARDENAFIL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5M8S2CU0TS
Rxcui349480

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2357-1VARDENAFIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2357VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 1 package rows20240529_d8a5cc4b-9d9d-43af-9ee4-57381aa6368a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNd8a5cc4b-9d9d-43af-9ee4-57381aa6368a1
349480vardenafil 20 MG Oral TabletSCDd8a5cc4b-9d9d-43af-9ee4-57381aa6368a1
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYd8a5cc4b-9d9d-43af-9ee4-57381aa6368a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2357-17133523570130 TABLET, FILM COATED in 1 BOTTLE (71335-2357-1) 2024-05-28NoNoCurrent