FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
71610-310
11-digit product format
716100310
Labeler code
71610
Product ID
71610-310_61980a1c-10b6-4f36-a192-1a82f38c1772
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
2019-01-31
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
71610-310-022023-01-30C16284748780-1f386c64a-083f-0266-e053-dadaa90a7c1aVardenafil Hydrochloride Tablets Rx Only These 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
71610-310-042023-01-30C16284748780-1f386c64a-083f-0266-e053-dadaa90a7c1aVardenafil Hydrochloride Tablets Rx Only These 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
71610-310-062023-01-30C16284748780-1f386c64a-083f-0266-e053-dadaa90a7c1aVardenafil Hydrochloride Tablets Rx Only These 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
71610-310-122023-01-30C16284748780-1f386c64a-083f-0266-e053-dadaa90a7c1aVardenafil Hydrochloride Tablets Rx Only These 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
71610-310-02Vardenafil Hydrochloride2 in 1 BOTTLETABLET21
71610-310-04Vardenafil Hydrochloride4 in 1 BOTTLETABLET41
71610-310-06Vardenafil Hydrochloride6 in 1 BOTTLETABLET61
71610-310-12Vardenafil Hydrochloride12 in 1 BOTTLETABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-310-02EA - Each71610-310b64b691a-e7ae-4765-b6a3-1c04e3418ef112019-10-07
71610-310-04EA - Each71610-31091f71986-442a-4df0-a4a2-02f2d5266c0512019-10-07
71610-310-06EA - Each71610-310d8b8a72c-2315-4fde-a54e-10743d6807c812019-10-07
71610-310-12EA - Each71610-310d6fe0b94-32f5-46cd-ada4-12436862828712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-310VARDENAFIL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20190817_d5470b59-59ff-455f-b602-36fc2839a941.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNd5470b59-59ff-455f-b602-36fc2839a9411
349480vardenafil 20 MG Oral TabletSCDd5470b59-59ff-455f-b602-36fc2839a9411
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYd5470b59-59ff-455f-b602-36fc2839a9411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-310-02716100310022 TABLET in 1 BOTTLE (71610-310-02) 2 tablet2019-08-020000-00-00NoNoCurrent
71610-310-04716100310044 TABLET in 1 BOTTLE (71610-310-04) 4 tablet2019-08-020000-00-00NoNoCurrent
71610-310-06716100310066 TABLET in 1 BOTTLE (71610-310-06) 6 tablet2019-08-020000-00-00NoNoCurrent
71610-310-127161003101212 TABLET in 1 BOTTLE (71610-310-12) 12 tablet2019-08-020000-00-00NoNoCurrent