FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-603
11-digit product format
716100603
Labeler code
71610
Product ID
71610-603_14c0a7a9-5273-4ee8-e063-6294a90a13dc
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
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
71610-603-08Tadalafil8 in 1 BOTTLETABLET, FILM COATED82
71610-603-11Tadalafil48 in 1 BOTTLETABLET, FILM COATED482
71610-603-23Tadalafil16 in 1 BOTTLETABLET, FILM COATED162
71610-603-36Tadalafil2940 in 1 BOTTLETABLET, FILM COATED29402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-603-08EA - Each71610-603294282df-0a31-4389-bd8e-cc13c41eea7112021-12-08
71610-603-11EA - Each71610-6031383d29f-f2c7-450a-a321-490d7fdf61f812021-12-08
71610-603-23EA - Each71610-6036ce77d10-115d-4153-8193-f8fdb37228a012021-12-08
71610-603-36EA - Each71610-60390f8cb85-c966-4708-99d4-a21fcc3eee2d12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-603TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20240330_d1dd9d05-e9d3-49ea-aeda-047536a27037.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSNd1dd9d05-e9d3-49ea-aeda-047536a270372
403957tadalafil 5 MG Oral TabletSCDd1dd9d05-e9d3-49ea-aeda-047536a270372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-603-08716100603088 TABLET, FILM COATED in 1 BOTTLE (71610-603-08) 2021-10-180000-00-00NoNoCurrent
71610-603-117161006031148 TABLET, FILM COATED in 1 BOTTLE (71610-603-11) 2021-10-180000-00-00NoNoCurrent
71610-603-237161006032316 TABLET, FILM COATED in 1 BOTTLE (71610-603-23) 2021-10-180000-00-00NoNoCurrent
71610-603-36716100603362940 TABLET, FILM COATED in 1 BOTTLE (71610-603-36) 2024-03-22NoNoHistorical