FDA.reportPublic FDA data

tadalafil

Product NDC
72789-344
11-digit product format
727890344
Labeler code
72789
Product ID
72789-344_40bb5cc5-f384-9589-e063-6394a90a4516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA215556
Marketing category
ANDA
Marketing start
2023-04-01
Substance
TADALAFIL
Active strength
20 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
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019

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
72789-344-15tadalafil15 in 1 BOTTLE, PLASTICTABLET, FILM COATED158
72789-344-90tadalafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-344-15EA - Each72789-3445a34b308-d024-4d67-aede-0f95d7093c2012023-09-05
72789-344-90EA - Each72789-344acb053a9-8c2c-420d-bdbc-8634f8d2bd9112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-344TADALAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7Current NDC, 2 package rows20241027_5de70f00-00ac-4656-883e-d1e07d5f71d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN5de70f00-00ac-4656-883e-d1e07d5f71d68
402019tadalafil 20 MG Oral TabletSCD5de70f00-00ac-4656-883e-d1e07d5f71d68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-344-157278903441515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-344-15) 2023-08-07NoNoCurrent
72789-344-907278903449090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-344-90) 2024-10-24NoNoCurrent