FDA.reportPublic FDA data

Tadalafil

Product NDC
63629-8157
11-digit product format
636298157
Labeler code
63629
Product ID
63629-8157_ee15251f-3006-4d6e-aa44-373d62deca1d
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
10 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
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
63629-8157-12024-05-13C16284748780-11030e365-0553-111a-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
63629-8157-22024-05-13C16284748780-11030e365-0553-111a-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
63629-8157-32024-05-13C16284748780-11030e365-0553-111a-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
63629-8157-42024-05-13C16284748780-11030e365-0553-111a-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
63629-8157-52024-05-13C16284748780-11030e365-0553-111a-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
63629-8157-12024-01-30C16284748780-11030e365-0553-111a-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
63629-8157-22024-01-30C16284748780-11030e365-0553-111a-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
63629-8157-32024-01-30C16284748780-11030e365-0553-111a-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
63629-8157-42024-01-30C16284748780-11030e365-0553-111a-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
63629-8157-52024-01-30C16284748780-11030e365-0553-111a-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
63629-8157-1Tadalafil30 in 1 BOTTLETABLET, FILM COATED305
63629-8157-2Tadalafil10 in 1 BOTTLETABLET, FILM COATED105
63629-8157-3Tadalafil60 in 1 BOTTLETABLET, FILM COATED605
63629-8157-4Tadalafil90 in 1 BOTTLETABLET, FILM COATED905
63629-8157-5Tadalafil20 in 1 BOTTLETABLET, FILM COATED205
63629-8157-6Tadalafil6 in 1 BOTTLETABLET, FILM COATED65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8157TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 6 package rows20240514_a3190ceb-fb3f-45f7-a12d-4c333edaadc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNa3190ceb-fb3f-45f7-a12d-4c333edaadc65
484814tadalafil 10 MG Oral TabletSCDa3190ceb-fb3f-45f7-a12d-4c333edaadc65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8157-16362981570130 TABLET, FILM COATED in 1 BOTTLE (63629-8157-1) 2019-07-030000-00-00NoNoCurrent
63629-8157-26362981570210 TABLET, FILM COATED in 1 BOTTLE (63629-8157-2) 2024-04-030000-00-00NoNoCurrent
63629-8157-36362981570360 TABLET, FILM COATED in 1 BOTTLE (63629-8157-3) 2024-04-030000-00-00NoNoCurrent
63629-8157-46362981570490 TABLET, FILM COATED in 1 BOTTLE (63629-8157-4) 2024-04-030000-00-00NoNoCurrent
63629-8157-56362981570520 TABLET, FILM COATED in 1 BOTTLE (63629-8157-5) 2024-04-030000-00-00NoNoCurrent
63629-8157-6636298157066 TABLET, FILM COATED in 1 BOTTLE (63629-8157-6) 2024-04-03NoNoHistorical