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

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9688-1Vardenafil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9688VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240406_31be68b0-ac7e-42d0-9435-1f0a329b63d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN31be68b0-ac7e-42d0-9435-1f0a329b63d8101
349480vardenafil 20 MG Oral TabletSCD31be68b0-ac7e-42d0-9435-1f0a329b63d8101
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY31be68b0-ac7e-42d0-9435-1f0a329b63d8101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9688-17133596880130 TABLET, FILM COATED in 1 BOTTLE (71335-9688-1) 2024-04-03NoNoCurrent