Tadalafil

Product NDC
71335-1823
11-digit product format
713351823
Labeler code
71335
Product ID
71335-1823_bb3b7333-03a8-465c-8845-7b9be87999af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209654
Marketing category
ANDA
Marketing start
2019-03-26
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
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
71335-1823-1Tadalafil90 in 1 BOTTLETABLET90103
71335-1823-2Tadalafil30 in 1 BOTTLETABLET30103
71335-1823-3Tadalafil10 in 1 BOTTLETABLET10103
71335-1823-4Tadalafil20 in 1 BOTTLETABLET20103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1823TADALAFIL TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20231108_2c2ec257-06bc-4ca4-9cf3-d0f49980e374.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757707tadalafil 2.5 MG Oral TabletPSN2c2ec257-06bc-4ca4-9cf3-d0f49980e374103
757707tadalafil 2.5 MG Oral TabletSCD2c2ec257-06bc-4ca4-9cf3-d0f49980e374103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1823-17133518230190 TABLET in 1 BOTTLE (71335-1823-1) 90 tablet2021-12-210000-00-00NoNoCurrent
71335-1823-27133518230230 TABLET in 1 BOTTLE (71335-1823-2) 30 tablet2021-12-210000-00-00NoNoCurrent
71335-1823-37133518230310 TABLET in 1 BOTTLE (71335-1823-3) 10 tablet2021-12-210000-00-00NoNoCurrent
71335-1823-47133518230420 TABLET in 1 BOTTLE (71335-1823-4) 20 tablet2021-12-210000-00-00NoNoCurrent