FDA.reportPublic FDA data

Tadalafil

Product NDC
71335-1255
11-digit product format
713351255
Labeler code
71335
Product ID
71335-1255_169c8d84-94fd-4024-b98e-a7184dbe83b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208934
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tadalafil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019

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
71335-1255-12024-05-20C16284748780-11030e365-3d6a-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
71335-1255-22024-05-20C16284748780-11030e365-3d6a-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
71335-1255-32024-05-20C16284748780-11030e365-3d6a-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
71335-1255-42024-05-20C16284748780-11030e365-3d6a-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
71335-1255-52024-05-20C16284748780-11030e365-3d6a-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
71335-1255-62024-05-20C16284748780-11030e365-3d6a-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
71335-1255-72024-05-20C16284748780-11030e365-3d6a-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
71335-1255-12024-01-30C16284748780-11030e365-3d6a-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
71335-1255-22024-01-30C16284748780-11030e365-3d6a-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
71335-1255-32024-01-30C16284748780-11030e365-3d6a-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
71335-1255-42024-01-30C16284748780-11030e365-3d6a-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
71335-1255-52024-01-30C16284748780-11030e365-3d6a-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
71335-1255-62024-01-30C16284748780-11030e365-3d6a-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
71335-1255-72024-01-30C16284748780-11030e365-3d6a-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
71335-1255-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED306
71335-1255-2Tadalafil10 in 1 BOTTLETABLET, FILM COATED106
71335-1255-3Tadalafil90 in 1 BOTTLETABLET, FILM COATED906
71335-1255-4Tadalafil5 in 1 BOTTLETABLET, FILM COATED56
71335-1255-5Tadalafil60 in 1 BOTTLETABLET, FILM COATED606
71335-1255-6Tadalafil20 in 1 BOTTLETABLET, FILM COATED206
71335-1255-7Tadalafil15 in 1 BOTTLETABLET, FILM COATED156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1255TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 7 package rows20240522_a73b0e6f-09fc-42d6-a678-1409ce746bd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSNa73b0e6f-09fc-42d6-a678-1409ce746bd16
402019tadalafil 20 MG Oral TabletSCDa73b0e6f-09fc-42d6-a678-1409ce746bd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1255-17133512550130 TABLET, FILM COATED in 1 BOTTLE (71335-1255-1) 2019-06-200000-00-00NoNoCurrent
71335-1255-27133512550210 TABLET, FILM COATED in 1 BOTTLE (71335-1255-2) 2019-06-210000-00-00NoNoCurrent
71335-1255-37133512550390 TABLET, FILM COATED in 1 BOTTLE (71335-1255-3) 2024-05-170000-00-00NoNoCurrent
71335-1255-4713351255045 TABLET, FILM COATED in 1 BOTTLE (71335-1255-4) 2024-05-170000-00-00NoNoCurrent
71335-1255-57133512550560 TABLET, FILM COATED in 1 BOTTLE (71335-1255-5) 2024-05-170000-00-00NoNoCurrent
71335-1255-67133512550620 TABLET, FILM COATED in 1 BOTTLE (71335-1255-6) 2024-05-170000-00-00NoNoCurrent
71335-1255-77133512550715 TABLET, FILM COATED in 1 BOTTLE (71335-1255-7) 2024-05-170000-00-00NoNoCurrent