FDA.reportPublic FDA data

Stendra

Product NDC
72384-751
11-digit product format
723840751
Labeler code
72384
Product ID
72384-751_02c03667-4518-4b43-ae10-f915132a0224
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avanafil
Dosage form
TABLET
Route
ORAL
Labeler
Metuchen Pharmaceuticals, LLC
Application
NDA202276
Marketing category
NDA
Marketing start
2013-12-27
Marketing end
0000-00-00
Substance
AVANAFIL
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
243aee53-eae8-56a8-2c9a-3e2b54bd0684Product name220250225

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72384-751-302026-01-29C16284748780-11030e365-3bdc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012
72384-751-302024-01-30C16284748780-11030e365-3bdc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA . STENDRA ® (avanafil) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72384-751-30Stendra30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72384-751-30EA - Each72384-751c4ac4b12-9683-458b-9267-68cec124a9cb12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72384-751STENDRA (AVANAFIL) TABLET [METUCHEN PHARMACEUTICALS, LLC]7Legacy NDC, 1 package rows20240724_fa7d93e3-b69b-4e02-8146-89760cd8e9d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291306avanafil 100 MG Oral TabletPSNfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291365avanafil 200 MG Oral TabletPSNfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291369avanafil 50 MG Oral TabletPSNfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291312Stendra 100 MG Oral TabletPSNfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291367Stendra 200 MG Oral TabletPSNfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291371Stendra 50 MG Oral TabletPSNfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291312avanafil 100 MG Oral Tablet [Stendra]SBDfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291367avanafil 200 MG Oral Tablet [Stendra]SBDfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291371avanafil 50 MG Oral Tablet [Stendra]SBDfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291306avanafil 100 MG Oral TabletSCDfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291365avanafil 200 MG Oral TabletSCDfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291369avanafil 50 MG Oral TabletSCDfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291312Stendra 100 MG Oral TabletSYfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291367Stendra 200 MG Oral TabletSYfa7d93e3-b69b-4e02-8146-89760cd8e9d67
1291371Stendra 50 MG Oral TabletSYfa7d93e3-b69b-4e02-8146-89760cd8e9d67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72384-751-307238407513030 TABLET in 1 BOTTLE (72384-751-30) 30 tablet2013-12-270000-00-00NoNoCurrent