FDA.reportPublic FDA data

Tadalafil

Product NDC
68071-2417
11-digit product format
680712417
Labeler code
68071
Product ID
68071-2417_e31258d1-a5d7-6c8c-e053-2a95a90a5299
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
5 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
68071-2417-12025-01-30C16284748780-12cef2736-ac7d-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
68071-2417-52025-01-30C16284748780-12cef2736-ac7d-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
68071-2417-62025-01-30C16284748780-12cef2736-ac7d-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
68071-2417-92025-01-30C16284748780-12cef2736-ac7d-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
68071-2417-1Tadalafil10 in 1 BOTTLETABLET104
68071-2417-5Tadalafil15 in 1 BOTTLETABLET154
68071-2417-6Tadalafil60 in 1 BOTTLETABLET604
68071-2417-9Tadalafil90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2417TADALAFIL TABLET [NUCARE PHARMACEUTICALS INC]4Legacy NDC, 4 package rows20231212_c32f7cdb-d011-a2b9-e053-2a95a90af02b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSNc32f7cdb-d011-a2b9-e053-2a95a90af02b4
403957tadalafil 5 MG Oral TabletSCDc32f7cdb-d011-a2b9-e053-2a95a90af02b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2417-16807124170110 in 1 BOTTLEHistorical
68071-2417-56807124170515 in 1 BOTTLEHistorical
68071-2417-66807124170660 TABLET in 1 BOTTLE (68071-2417-6) 60 tablet2021-05-250000-00-00NoNoCurrent
68071-2417-96807124170990 TABLET in 1 BOTTLE (68071-2417-9) 90 tablet2021-05-250000-00-00NoNoCurrent