FDA.reportPublic FDA data

Tadalafil

Product NDC
72789-407
11-digit product format
727890407
Labeler code
72789
Product ID
72789-407_32461a60-5965-a455-e063-6294a90a3a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA211298
Marketing category
ANDA
Marketing start
2020-11-02
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-407-30Tadalafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3012
72789-407-90Tadalafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-407-30EA - Each72789-4074767906e-b47b-4e13-9405-e9b9704e28f812024-07-12
72789-407-90EA - Each72789-4074f723f6a-0a97-4c4b-8547-e6b0efbb10e812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-407TADALAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12Current NDC, 2 package rows20250410_e899da81-a28e-4a7e-a0e6-ed6d557c0bcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSNe899da81-a28e-4a7e-a0e6-ed6d557c0bcd12
403957tadalafil 5 MG Oral TabletSCDe899da81-a28e-4a7e-a0e6-ed6d557c0bcd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-407-307278904073030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-407-30) 2024-06-10NoNoCurrent
72789-407-907278904079090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-407-90) 2024-06-11NoNoCurrent