FDA.reportPublic FDA data

Tadalafil

Product NDC
71335-1620
11-digit product format
713351620
Labeler code
71335
Product ID
71335-1620_c7f976f4-9d3b-4c8e-b4ae-3270ba8d8a00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209167
Marketing category
ANDA
Marketing start
2020-04-03
Substance
TADALAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tadalafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui484814

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
71335-1620-12024-05-21C16284748780-11030e365-6fee-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
71335-1620-22024-05-21C16284748780-11030e365-6fee-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
71335-1620-32024-05-21C16284748780-11030e365-6fee-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
71335-1620-42024-05-21C16284748780-11030e365-6fee-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
71335-1620-52024-05-21C16284748780-11030e365-6fee-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
71335-1620-12024-01-30C16284748780-11030e365-6fee-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
71335-1620-22024-01-30C16284748780-11030e365-6fee-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
71335-1620-32024-01-30C16284748780-11030e365-6fee-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
71335-1620-42024-01-30C16284748780-11030e365-6fee-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
71335-1620-52024-01-30C16284748780-11030e365-6fee-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
71335-1620-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED30103
71335-1620-2Tadalafil10 in 1 BOTTLETABLET, FILM COATED10103
71335-1620-3Tadalafil60 in 1 BOTTLETABLET, FILM COATED60103
71335-1620-4Tadalafil90 in 1 BOTTLETABLET, FILM COATED90103
71335-1620-5Tadalafil20 in 1 BOTTLETABLET, FILM COATED20103
71335-1620-6Tadalafil6 in 1 BOTTLETABLET, FILM COATED6103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1620TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20241121_f8def23c-55ea-4796-9735-dbcb25104835.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNf8def23c-55ea-4796-9735-dbcb25104835103
484814tadalafil 10 MG Oral TabletSCDf8def23c-55ea-4796-9735-dbcb25104835103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1620-17133516200130 TABLET, FILM COATED in 1 BOTTLE (71335-1620-1) 2020-06-240000-00-00NoNoCurrent
71335-1620-27133516200210 TABLET, FILM COATED in 1 BOTTLE (71335-1620-2) 2020-08-200000-00-00NoNoCurrent
71335-1620-37133516200360 TABLET, FILM COATED in 1 BOTTLE (71335-1620-3) 2021-01-130000-00-00NoNoCurrent
71335-1620-47133516200490 TABLET, FILM COATED in 1 BOTTLE (71335-1620-4) 2020-06-030000-00-00NoNoCurrent
71335-1620-57133516200520 TABLET, FILM COATED in 1 BOTTLE (71335-1620-5) 2024-10-310000-00-00NoNoCurrent
71335-1620-6713351620066 TABLET, FILM COATED in 1 BOTTLE (71335-1620-6) 2024-10-31NoNoCurrent