FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
0527-2801
11-digit product format
005272801
Labeler code
0527
Product ID
0527-2801_0a6ac33c-4a1f-4d07-b60e-453bb7111c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA209057
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5M8S2CU0TS
Rxcui349478, 349479, 349480, 402273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-2801-322020-04-17C16284748780-19d75b9d0-bc62-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE TABLETS. VARDENAFIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
0527-2801-322020-01-31C16284748780-19d75b9d0-bc62-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE TABLETS. VARDENAFIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-2801-32Vardenafil Hydrochloride30 in 1 BOTTLETABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2801VARDENAFIL HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]7Current NDC, Legacy NDC, 1 package rows20240809_2782efed-6198-47b9-81ac-3e255e2ab7f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
349479vardenafil HCl 10 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
402273vardenafil HCl 2.5 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
349479vardenafil 10 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
402273vardenafil 2.5 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
349480vardenafil 20 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG Oral TabletPSN3b03952b-d404-09cd-e063-6294a90a8b2c1
349478vardenafil 5 MG Oral TabletSCD3b03952b-d404-09cd-e063-6294a90a8b2c1
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY3b03952b-d404-09cd-e063-6294a90a8b2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-2801-320052728013230 TABLET in 1 BOTTLE (0527-2801-32) 30 tablet2018-11-010000-00-00NoNoCurrent