FDA.reportPublic FDA data

tadalafil

Product NDC
82804-112
11-digit product format
828040112
Labeler code
82804
Product ID
82804-112_a080fd7b-7bde-40ad-ac8c-4c85453be8db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209250
Marketing category
ANDA
Marketing start
2019-03-26
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
82804-112-10tadalafil10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
82804-112-30tadalafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
82804-112-90tadalafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-112-30EA - Each82804-11247d08c29-ab20-4c5e-b712-de3a8f00385212024-08-12
82804-112-90EA - Each82804-112fb1d6934-fad4-4e57-a838-02c7b1506bb112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-112TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, 3 package rows20240726_929e391e-b74b-4ccd-8690-16ffcece7a30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN929e391e-b74b-4ccd-8690-16ffcece7a303
402019tadalafil 20 MG Oral TabletSCD929e391e-b74b-4ccd-8690-16ffcece7a303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-112-108280401121010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-10) 2024-07-18NoNoCurrent
82804-112-308280401123030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-30) 2024-06-26NoNoCurrent
82804-112-908280401129090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-112-90) 2024-06-17NoNoCurrent