FDA.reportPublic FDA data

TADALAFIL

Product NDC
71335-2363
11-digit product format
713352363
Labeler code
71335
Product ID
71335-2363_6f71e600-ca1c-4d61-9e9f-859eef56f665
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210609
Marketing category
ANDA
Marketing start
2022-01-18
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
2026-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2363-1TADALAFIL90 in 1 BOTTLETABLET90101
71335-2363-2TADALAFIL30 in 1 BOTTLETABLET30101
71335-2363-3TADALAFIL10 in 1 BOTTLETABLET10101
71335-2363-4TADALAFIL20 in 1 BOTTLETABLET20101
71335-2363-5TADALAFIL60 in 1 BOTTLETABLET60101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2363TADALAFIL TABLET [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20240502_b3a58c17-f260-4125-abd1-27da00bb0719.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757707tadalafil 2.5 MG Oral TabletPSNb3a58c17-f260-4125-abd1-27da00bb0719102
757707tadalafil 2.5 MG Oral TabletSCDb3a58c17-f260-4125-abd1-27da00bb0719102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2363-17133523630190 TABLET in 1 BOTTLE (71335-2363-1) 90 tablet2024-04-30NoNoCurrent
71335-2363-27133523630230 TABLET in 1 BOTTLE (71335-2363-2) 30 tablet2024-04-30NoNoCurrent
71335-2363-37133523630310 TABLET in 1 BOTTLE (71335-2363-3) 10 tablet2024-04-30NoNoCurrent
71335-2363-47133523630420 TABLET in 1 BOTTLE (71335-2363-4) 20 tablet2024-04-30NoNoCurrent
71335-2363-57133523630560 TABLET in 1 BOTTLE (71335-2363-5)60 tablet2026-05-270Current