Vardenafil Hydrochloride

Product NDC
71335-9696
11-digit product format
713359696
Labeler code
71335
Product ID
71335-9696_c4b53c3e-e0c7-4368-beda-8c27a32ad5c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209057
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5M8S2CU0TS
Rxcui349479

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
71335-9696-1Vardenafil Hydrochloride30 in 1 BOTTLETABLET30103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9696VARDENAFIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240918_8791997d-3b86-45af-988f-808e259da506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349479vardenafil HCl 10 MG Oral TabletPSN8791997d-3b86-45af-988f-808e259da506103
349479vardenafil 10 MG Oral TabletSCD8791997d-3b86-45af-988f-808e259da506103
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY8791997d-3b86-45af-988f-808e259da506103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9696-17133596960130 TABLET in 1 BOTTLE (71335-9696-1) 30 tablet2023-04-12NoNoHistorical