FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-581
11-digit product format
716100581
Labeler code
71610
Product ID
71610-581_21f23cde-ebd8-aa67-e063-6394a90a7150
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
10 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
TADALAFIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui484814

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
71610-581-04Tadalafil4 in 1 BOTTLETABLET, FILM COATED44
71610-581-06Tadalafil6 in 1 BOTTLE, PLASTICTABLET, FILM COATED64
71610-581-12Tadalafil12 in 1 BOTTLE, PLASTICTABLET, FILM COATED124
71610-581-39Tadalafil1440 in 1 BOTTLETABLET, FILM COATED14404
71610-581-52Tadalafil18 in 1 BOTTLETABLET, FILM COATED184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-581-04EA - Each71610-5818e44c90b-e6fd-41db-8842-bbd4c1994cd112021-09-07
71610-581-06EA - Each71610-58123bf1e70-c5e5-4c00-8207-358cf78bcb9812024-01-04
71610-581-12EA - Each71610-5811f82e60b-61a3-40af-951b-492f7c684a4712021-09-07
71610-581-39EA - Each71610-58132ae54fe-2adb-4f47-a6cb-9b729bc8f7ba12024-05-16
71610-581-52EA - Each71610-581fc2d3af3-ea46-4ecc-9487-7dba4be4feaa12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-581TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 5 package rows20240915_f2e8821e-04c9-4812-8c9e-39340775cc6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNf2e8821e-04c9-4812-8c9e-39340775cc6e4
484814tadalafil 10 MG Oral TabletSCDf2e8821e-04c9-4812-8c9e-39340775cc6e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-581-04716100581044 TABLET, FILM COATED in 1 BOTTLE (71610-581-04) 2021-07-120000-00-00NoNoCurrent
71610-581-06716100581066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-06) 2023-02-01NoNoCurrent
71610-581-127161005811212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12) 2021-07-120000-00-00NoNoCurrent
71610-581-39716100581391440 TABLET, FILM COATED in 1 BOTTLE (71610-581-39) 2024-04-03NoNoCurrent
71610-581-527161005815218 TABLET, FILM COATED in 1 BOTTLE (71610-581-52) 2024-09-05NoNoCurrent