FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-324
11-digit product format
716100324
Labeler code
71610
Product ID
71610-324_6d71597b-631f-41b8-984b-d53aa6ca10d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208934
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
5 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
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-324-082023-01-30C16284748780-1f386c649-d034-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71610-324-112023-01-30C16284748780-1f386c649-d034-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71610-324-232023-01-30C16284748780-1f386c649-d034-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003
71610-324-472023-01-30C16284748780-1f386c649-d034-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-324-08Tadalafil8 in 1 BOTTLETABLET, FILM COATED81
71610-324-11Tadalafil48 in 1 BOTTLETABLET, FILM COATED481
71610-324-23Tadalafil16 in 1 BOTTLETABLET, FILM COATED161
71610-324-47Tadalafil24 in 1 BOTTLETABLET, FILM COATED241

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-324-08EA - Each71610-324d45aea2a-988d-4662-8a07-ab8f5102319712019-10-07
71610-324-11EA - Each71610-3243521cb85-edd7-49db-bdcc-0999d6bd574912019-10-07
71610-324-23EA - Each71610-324eb77ed1e-2c37-4f31-bbb7-f1fc1986c76a12019-10-07
71610-324-47EA - Each71610-3241f2800bf-98d2-4f19-8abb-6de8bf0660fc12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-324TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20190912_059b4496-bbfd-4058-ab03-91c5c223b945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN059b4496-bbfd-4058-ab03-91c5c223b9451
403957tadalafil 5 MG Oral TabletPSN059b4496-bbfd-4058-ab03-91c5c223b9451
402019tadalafil 20 MG Oral TabletSCD059b4496-bbfd-4058-ab03-91c5c223b9451
403957tadalafil 5 MG Oral TabletSCD059b4496-bbfd-4058-ab03-91c5c223b9451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-324-08716100324088 TABLET, FILM COATED in 1 BOTTLE (71610-324-08) 2019-08-130000-00-00NoNoCurrent
71610-324-117161003241148 TABLET, FILM COATED in 1 BOTTLE (71610-324-11) 2019-08-130000-00-00NoNoCurrent
71610-324-237161003242316 TABLET, FILM COATED in 1 BOTTLE (71610-324-23) 2019-08-130000-00-00NoNoCurrent
71610-324-477161003244724 TABLET, FILM COATED in 1 BOTTLE (71610-324-47) 2019-08-160000-00-00NoNoCurrent