FDA.reportPublic FDA data

Tadalafil

Product NDC
71205-268
11-digit product format
712050268
Labeler code
71205
Product ID
71205-268_cfe4f78a-2bff-4f77-a582-f9027a8eb62e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209167
Marketing category
ANDA
Marketing start
2019-03-27
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
71205-268-10Tadalafil10 in 1 BOTTLETABLET, FILM COATED104
71205-268-30Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
71205-268-60Tadalafil60 in 1 BOTTLETABLET, FILM COATED604
71205-268-90Tadalafil90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-268-10EA - Each71205-2685cfc4535-6347-49ee-8656-639dae9c9f4a12019-11-12
71205-268-30EA - Each71205-268f7522449-495d-4747-b599-eff27a65b73312019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-268TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20220409_6fa9d4fa-86c9-4791-b28b-78e8b9341cea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN6fa9d4fa-86c9-4791-b28b-78e8b9341cea4
402019tadalafil 20 MG Oral TabletSCD6fa9d4fa-86c9-4791-b28b-78e8b9341cea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-268-107120502681010 TABLET, FILM COATED in 1 BOTTLE (71205-268-10) 2019-07-010000-00-00NoNoCurrent
71205-268-307120502683030 TABLET, FILM COATED in 1 BOTTLE (71205-268-30) 2019-05-010000-00-00NoNoCurrent
71205-268-607120502686060 TABLET, FILM COATED in 1 BOTTLE (71205-268-60) 2019-05-010000-00-00NoNoCurrent
71205-268-907120502689090 TABLET, FILM COATED in 1 BOTTLE (71205-268-90) 2019-05-010000-00-00NoNoCurrent