FDA.reportPublic FDA data

Tadalafil

Product NDC
68071-2421
11-digit product format
680712421
Labeler code
68071
Product ID
68071-2421_ebcdf21f-b60e-108b-e053-2995a90adb7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209654
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
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
68071-2421-12025-01-30C16284748780-12cef2736-6c7d-d83d-e063-dadaa90ab31fThese 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
68071-2421-42025-01-30C16284748780-12cef2736-6c7d-d83d-e063-dadaa90ab31fThese 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
68071-2421-52025-01-30C16284748780-12cef2736-6c7d-d83d-e063-dadaa90ab31fThese 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
68071-2421-62025-01-30C16284748780-12cef2736-6c7d-d83d-e063-dadaa90ab31fThese 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
68071-2421-1Tadalafil10 in 1 BOTTLETABLET104
68071-2421-4Tadalafil24 in 1 BOTTLETABLET244
68071-2421-5Tadalafil5 in 1 BOTTLETABLET54
68071-2421-6Tadalafil60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2421TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 4 package rows20221027_c3409762-3b2b-1cfc-e053-2995a90ab91b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSNc3409762-3b2b-1cfc-e053-2995a90ab91b4
402019tadalafil 20 MG Oral TabletSCDc3409762-3b2b-1cfc-e053-2995a90ab91b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2421-16807124210110 TABLET in 1 BOTTLE (68071-2421-1) 10 tablet2021-05-260000-00-00NoNoCurrent
68071-2421-46807124210424 TABLET in 1 BOTTLE (68071-2421-4) 24 tablet2021-05-260000-00-00NoNoCurrent
68071-2421-5680712421055 TABLET in 1 BOTTLE (68071-2421-5) 5 tablet2021-05-260000-00-00NoNoCurrent
68071-2421-66807124210660 TABLET in 1 BOTTLE (68071-2421-6) 60 tablet2021-05-260000-00-00NoNoCurrent