FDA.reportPublic FDA data

Tadalafil

Product NDC
63629-7943
11-digit product format
636297943
Labeler code
63629
Product ID
63629-7943_63a6ae33-49d7-41f8-9974-d8d805812118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210255
Marketing category
ANDA
Marketing start
2019-02-05
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
63629-7943-12024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003
63629-7943-22024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003
63629-7943-32024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003
63629-7943-42024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003
63629-7943-52024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003
63629-7943-62024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003
63629-7943-72024-01-30C16284748780-11030e365-1d33-111a-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 administration Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7943-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED308
63629-7943-2Tadalafil10 in 1 BOTTLETABLET, FILM COATED108
63629-7943-3Tadalafil90 in 1 BOTTLETABLET, FILM COATED908
63629-7943-4Tadalafil5 in 1 BOTTLETABLET, FILM COATED58
63629-7943-5Tadalafil60 in 1 BOTTLETABLET, FILM COATED608
63629-7943-6Tadalafil20 in 1 BOTTLETABLET, FILM COATED208
63629-7943-7Tadalafil15 in 1 BOTTLETABLET, FILM COATED158

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7943TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]8Legacy NDC, 7 package rows20220118_63a6ae33-49d7-41f8-9974-d8d805812118.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN63a6ae33-49d7-41f8-9974-d8d8058121188
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD63a6ae33-49d7-41f8-9974-d8d8058121188
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY63a6ae33-49d7-41f8-9974-d8d8058121188

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7943-16362979430130 TABLET, FILM COATED in 1 BOTTLE (63629-7943-1) 2019-03-130000-00-00NoNoCurrent
63629-7943-26362979430210 TABLET, FILM COATED in 1 BOTTLE (63629-7943-2) 2019-03-130000-00-00NoNoCurrent
63629-7943-36362979430390 TABLET, FILM COATED in 1 BOTTLE (63629-7943-3) 2019-03-130000-00-00NoNoCurrent
63629-7943-4636297943045 TABLET, FILM COATED in 1 BOTTLE (63629-7943-4) 2019-03-130000-00-00NoNoCurrent
63629-7943-56362979430560 TABLET, FILM COATED in 1 BOTTLE (63629-7943-5) 2019-03-130000-00-00NoNoCurrent
63629-7943-66362979430620 TABLET, FILM COATED in 1 BOTTLE (63629-7943-6) 2019-03-130000-00-00NoNoCurrent
63629-7943-76362979430715 TABLET, FILM COATED in 1 BOTTLE (63629-7943-7) 2019-03-130000-00-00NoNoCurrent