FDA.reportPublic FDA data

Tadalafil

Product NDC
82804-040
11-digit product format
828040040
Labeler code
82804
Product ID
82804-040_7dfb450b-4d39-40e7-b115-9a96023052a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
82804-040-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED301
82804-040-60Tadalafil60 in 1 BOTTLETABLET, FILM COATED601
82804-040-90Tadalafil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-040TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20231116_7dfb450b-4d39-40e7-b115-9a96023052a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN7dfb450b-4d39-40e7-b115-9a96023052a01
403957tadalafil 5 MG Oral TabletSCD7dfb450b-4d39-40e7-b115-9a96023052a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-040-308280400403030 TABLET, FILM COATED in 1 BOTTLE (82804-040-30) 2023-11-10NoNoCurrent
82804-040-608280400406060 TABLET, FILM COATED in 1 BOTTLE (82804-040-60) 2023-11-10NoNoCurrent
82804-040-908280400409090 TABLET, FILM COATED in 1 BOTTLE (82804-040-90) 2023-11-10NoNoCurrent