FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-567
11-digit product format
716100567
Labeler code
71610
Product ID
71610-567_2d964f58-b0bb-183f-e063-6394a90a232f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209744
Marketing category
ANDA
Marketing start
2021-01-21
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
71610-567-04Tadalafil4 in 1 BOTTLETABLET, FILM COATED43
71610-567-12Tadalafil12 in 1 BOTTLETABLET, FILM COATED123
71610-567-31Tadalafil600 in 1 BOTTLETABLET, FILM COATED6003
71610-567-52Tadalafil18 in 1 BOTTLETABLET, FILM COATED183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-567-04EA - Each71610-56783a48cc9-14ee-4346-89d6-8fb6d65be91c12021-08-05
71610-567-12EA - Each71610-5678ddcee49-5d0a-4d4b-b7f0-6e2f85f9bb0a12021-08-05
71610-567-31EA - Each71610-567b42fde00-3139-493b-8481-31d3222ad9df12024-05-16
71610-567-52EA - Each71610-5674cdb01c4-41bb-4f77-85cc-b3c92c7f6ea612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-567TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 4 package rows20250212_bce03930-14c5-401f-ad17-06b7709983bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSNbce03930-14c5-401f-ad17-06b7709983bc3
402019tadalafil 20 MG Oral TabletSCDbce03930-14c5-401f-ad17-06b7709983bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-567-04716100567044 TABLET, FILM COATED in 1 BOTTLE (71610-567-04) 2021-06-100000-00-00NoNoCurrent
71610-567-127161005671212 TABLET, FILM COATED in 1 BOTTLE (71610-567-12) 2021-06-100000-00-00NoNoCurrent
71610-567-3171610056731600 TABLET, FILM COATED in 1 BOTTLE (71610-567-31) 2024-03-22NoNoHistorical
71610-567-527161005675218 TABLET, FILM COATED in 1 BOTTLE (71610-567-52) 2025-02-05NoNoHistorical