FDA.reportPublic FDA data

Tadalafil

Product NDC
50090-5344
11-digit product format
500905344
Labeler code
50090
Product ID
50090-5344_c4a2a319-3628-4627-aae5-0b477537d82f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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
50090-5344-02025-01-30C16284748780-1f386c649-c303-0266-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
50090-5344-12025-01-30C16284748780-1f386c649-c303-0266-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
50090-5344-02023-02-06C16284748780-1f386c649-c303-0266-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
50090-5344-12023-02-06C16284748780-1f386c649-c303-0266-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
50090-5344-02023-01-30C16284748780-1f386c649-c303-0266-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
50090-5344-12023-01-30C16284748780-1f386c649-c303-0266-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
50090-5344-0Tadalafil90 in 1 BOTTLETABLET903
50090-5344-1Tadalafil30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5344TADALAFIL TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20230208_599fc25a-a7af-4eeb-971f-8cf690b47e45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN599fc25a-a7af-4eeb-971f-8cf690b47e453
403957tadalafil 5 MG Oral TabletSCD599fc25a-a7af-4eeb-971f-8cf690b47e453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5344-05009053440090 TABLET in 1 BOTTLE (50090-5344-0) 90 tablet2020-11-040000-00-00NoNoCurrent
50090-5344-15009053440130 TABLET in 1 BOTTLE (50090-5344-1) 30 tablet2020-11-040000-00-00NoNoCurrent