Vardenafil Hydrochloride

Product NDC
72162-2235
11-digit product format
721622235
Labeler code
72162
Product ID
72162-2235_cecc1421-aaad-44e4-9358-1535d77fc2ec
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
72162-2235-3Vardenafil Hydrochloride30 in 1 BOTTLETABLET30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2235-3EA - Each72162-22350ddf69fd-6827-489d-8900-0ccc9726fedb12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2235VARDENAFIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240920_6d2859a7-6def-455f-856b-9db86b1fd355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349479vardenafil HCl 10 MG Oral TabletPSN6d2859a7-6def-455f-856b-9db86b1fd355103
349479vardenafil 10 MG Oral TabletSCD6d2859a7-6def-455f-856b-9db86b1fd355103
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY6d2859a7-6def-455f-856b-9db86b1fd355103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2235-37216222350330 TABLET in 1 BOTTLE (72162-2235-3) 30 tablet2024-09-06NoNoCurrent