FDA.reportPublic FDA data

VARDENAFIL

Product NDC
71610-477
11-digit product format
716100477
Labeler code
71610
Product ID
71610-477_9d2796f2-b596-4588-96c8-f99407d3e671
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208960
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE20 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
71610-477-02VARDENAFIL2 in 1 BOTTLETABLET, FILM COATED22
71610-477-04VARDENAFIL4 in 1 BOTTLETABLET, FILM COATED42
71610-477-06VARDENAFIL6 in 1 BOTTLETABLET, FILM COATED62
71610-477-12VARDENAFIL12 in 1 BOTTLETABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-477-06EA - Each71610-4778d1604a0-15e5-4802-85e6-bb28c845a1e712021-08-05
71610-477-12EA - Each71610-477b49f3761-ed0b-4340-b461-8bbf273e164612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-477VARDENAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20210504_c70a9c8e-46b0-489d-bbda-2d7fca4b629f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNc70a9c8e-46b0-489d-bbda-2d7fca4b629f2
349480vardenafil 20 MG Oral TabletSCDc70a9c8e-46b0-489d-bbda-2d7fca4b629f2
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYc70a9c8e-46b0-489d-bbda-2d7fca4b629f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-477-02716100477022 TABLET, FILM COATED in 1 BOTTLE (71610-477-02) 2020-11-050000-00-00NoNoCurrent
71610-477-04716100477044 TABLET, FILM COATED in 1 BOTTLE (71610-477-04) 2020-10-230000-00-00NoNoCurrent
71610-477-06716100477066 TABLET, FILM COATED in 1 BOTTLE (71610-477-06) 2021-05-030000-00-00NoNoCurrent
71610-477-127161004771212 TABLET, FILM COATED in 1 BOTTLE (71610-477-12) 2021-04-070000-00-00NoNoCurrent