FDA.reportPublic FDA data

Tadalafil

Product NDC
50436-0372
11-digit product format
504360372
Labeler code
50436
Product ID
50436-0372_4bfd6267-6bbb-4590-ac91-84a09e9413f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA209167
Marketing category
ANDA
Marketing start
2019-03-27
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
50436-0372-12024-01-30C16284748780-11030e365-6b5e-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
50436-0372-22024-01-30C16284748780-11030e365-6b5e-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
50436-0372-32024-01-30C16284748780-11030e365-6b5e-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
50436-0372-42024-01-30C16284748780-11030e365-6b5e-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
50436-0372-52024-01-30C16284748780-11030e365-6b5e-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
50436-0372-1Tadalafil3 in 1 BOTTLETABLET, FILM COATED32
50436-0372-2Tadalafil6 in 1 BOTTLETABLET, FILM COATED62
50436-0372-3Tadalafil9 in 1 BOTTLETABLET, FILM COATED92
50436-0372-4Tadalafil18 in 1 BOTTLETABLET, FILM COATED182
50436-0372-5Tadalafil27 in 1 BOTTLETABLET, FILM COATED272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0372TADALAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 5 package rows20220922_59bcf8b4-9829-4673-bd47-7dedb79a9548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN59bcf8b4-9829-4673-bd47-7dedb79a95482
402019tadalafil 20 MG Oral TabletSCD59bcf8b4-9829-4673-bd47-7dedb79a95482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0372-1504360372013 TABLET, FILM COATED in 1 BOTTLE (50436-0372-1) 2022-09-210000-00-00NoNoCurrent
50436-0372-2504360372026 TABLET, FILM COATED in 1 BOTTLE (50436-0372-2) 2022-09-210000-00-00NoNoCurrent
50436-0372-3504360372039 TABLET, FILM COATED in 1 BOTTLE (50436-0372-3) 2022-09-210000-00-00NoNoCurrent
50436-0372-45043603720418 TABLET, FILM COATED in 1 BOTTLE (50436-0372-4) 2022-09-210000-00-00NoNoCurrent
50436-0372-55043603720527 TABLET, FILM COATED in 1 BOTTLE (50436-0372-5) 2022-09-210000-00-00NoNoCurrent