FDA.reportPublic FDA data

Tadalafil

Product NDC
71335-1239
11-digit product format
713351239
Labeler code
71335
Product ID
71335-1239_17066a78-5ea3-428c-adb8-a679db3fc658
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 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
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
71335-1239-12024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-22024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-32024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-42024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-52024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-62024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-72024-01-30C16284748780-11030e365-64bf-111a-e063-dadaa90a10e2These 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
71335-1239-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED303
71335-1239-2Tadalafil10 in 1 BOTTLETABLET, FILM COATED103
71335-1239-3Tadalafil90 in 1 BOTTLETABLET, FILM COATED903
71335-1239-4Tadalafil5 in 1 BOTTLETABLET, FILM COATED53
71335-1239-5Tadalafil60 in 1 BOTTLETABLET, FILM COATED603
71335-1239-6Tadalafil20 in 1 BOTTLETABLET, FILM COATED203
71335-1239-7Tadalafil15 in 1 BOTTLETABLET, FILM COATED153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1239TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]3Legacy NDC, 7 package rows20220225_17066a78-5ea3-428c-adb8-a679db3fc658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN17066a78-5ea3-428c-adb8-a679db3fc6583
402019tadalafil 20 MG Oral TabletSCD17066a78-5ea3-428c-adb8-a679db3fc6583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1239-17133512390130 TABLET, FILM COATED in 1 BOTTLE (71335-1239-1) 2019-06-050000-00-00NoNoCurrent
71335-1239-27133512390210 TABLET, FILM COATED in 1 BOTTLE (71335-1239-2) 2019-06-140000-00-00NoNoCurrent
71335-1239-37133512390390 TABLET, FILM COATED in 1 BOTTLE (71335-1239-3) 2022-02-230000-00-00NoNoCurrent
71335-1239-4713351239045 TABLET, FILM COATED in 1 BOTTLE (71335-1239-4) 2019-05-300000-00-00NoNoCurrent
71335-1239-57133512390560 TABLET, FILM COATED in 1 BOTTLE (71335-1239-5) 2022-02-230000-00-00NoNoCurrent
71335-1239-67133512390620 TABLET, FILM COATED in 1 BOTTLE (71335-1239-6) 2022-02-230000-00-00NoNoCurrent
71335-1239-77133512390715 TABLET, FILM COATED in 1 BOTTLE (71335-1239-7) 2022-02-230000-00-00NoNoCurrent