FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
71610-508
11-digit product format
716100508
Labeler code
71610
Product ID
71610-508_56a14d26-0c09-4a32-bec0-d4fba1003548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209057
Marketing category
ANDA
Marketing start
2018-11-01
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
71610-508-02Vardenafil Hydrochloride2 in 1 BOTTLETABLET21
71610-508-04Vardenafil Hydrochloride4 in 1 BOTTLETABLET41
71610-508-12Vardenafil Hydrochloride12 in 1 BOTTLETABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-508-02EA - Each71610-50813ddfd98-d8f6-44e1-a504-385d51e6007a12021-03-02
71610-508-04EA - Each71610-508bb08ce16-6962-4cac-94b9-3be17330f94612021-03-02
71610-508-12EA - Each71610-508f8aaebcf-4b55-4b2e-b5ce-919e3b40ec9312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-508VARDENAFIL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20210129_09366eb3-93e0-41d9-bf9a-24335ed3555f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN09366eb3-93e0-41d9-bf9a-24335ed3555f1
349480vardenafil 20 MG Oral TabletSCD09366eb3-93e0-41d9-bf9a-24335ed3555f1
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY09366eb3-93e0-41d9-bf9a-24335ed3555f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-508-02716100508022 TABLET in 1 BOTTLE (71610-508-02) 2 tablet2020-12-210000-00-00NoNoCurrent
71610-508-04716100508044 TABLET in 1 BOTTLE (71610-508-04) 4 tablet2020-12-210000-00-00NoNoCurrent
71610-508-127161005081212 TABLET in 1 BOTTLE (71610-508-12) 12 tablet2020-12-210000-00-00NoNoCurrent