TADALAFIL

Product NDC
72189-145
11-digit product format
721890145
Labeler code
72189
Product ID
72189-145_397f5fde-810b-642f-e063-6294a90ae47b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TADALAFIL
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA209654
Marketing category
ANDA
Marketing start
2020-11-12
Substance
TADALAFIL
Active strength
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui403957

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
72189-145-302025-06-09C16284748780-12cef2736-5fb6-d83d-e063-dadaa90ab31fTadalafil
72189-145-302025-01-30C16284748780-12cef2736-5fb6-d83d-e063-dadaa90ab31fTadalafil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-145-30TADALAFIL30 in 1 BOTTLETABLET304
72189-145-90TADALAFIL90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-145TADALAFIL TABLET [DIRECT RX]1Current NDC, Legacy NDC, 2 package rows20201113_b3ee8325-bcb2-43fd-e053-2a95a90a08c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSNb3ee8325-bcb2-43fd-e053-2a95a90a08c84
403957tadalafil 5 MG Oral TabletSCDb3ee8325-bcb2-43fd-e053-2a95a90a08c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-145-307218901453030 TABLET in 1 BOTTLE (72189-145-30) 30 tablet2020-11-120000-00-00NoNoCurrent
72189-145-907218901459090 TABLET in 1 BOTTLE (72189-145-90) 90 tablet2020-11-12NoNoCurrent