FDA.reportPublic FDA data

Tadalafil

Product NDC
63629-8409
11-digit product format
636298409
Labeler code
63629
Product ID
63629-8409_df1f450c-40c6-499e-af71-b3300db4f62c
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
2019-03-27
Substance
TADALAFIL
Active strength
2.5 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
TADALAFIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui757707

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8409-1Tadalafil90 in 1 BOTTLETABLET, FILM COATED90105
63629-8409-2Tadalafil30 in 1 BOTTLETABLET, FILM COATED30105
63629-8409-3Tadalafil10 in 1 BOTTLETABLET, FILM COATED10105
63629-8409-4Tadalafil20 in 1 BOTTLETABLET, FILM COATED20105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8409TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20241109_07567ae5-7345-4ab1-9b2c-c586c4da0427.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757707tadalafil 2.5 MG Oral TabletPSN07567ae5-7345-4ab1-9b2c-c586c4da0427105
757707tadalafil 2.5 MG Oral TabletSCD07567ae5-7345-4ab1-9b2c-c586c4da0427105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8409-16362984090190 TABLET, FILM COATED in 1 BOTTLE (63629-8409-1) 2021-01-070000-00-00NoNoCurrent
63629-8409-26362984090230 TABLET, FILM COATED in 1 BOTTLE (63629-8409-2) 2022-06-140000-00-00NoNoCurrent
63629-8409-36362984090310 TABLET, FILM COATED in 1 BOTTLE (63629-8409-3) 2024-10-290000-00-00NoNoCurrent
63629-8409-46362984090420 TABLET, FILM COATED in 1 BOTTLE (63629-8409-4) 2024-10-290000-00-00NoNoCurrent