FDA.reportPublic FDA data

Tadalafil

Product NDC
71610-896
Requested package NDC
71610-896-52
11-digit product format
716100896
Labeler code
71610
Product ID
71610-896_32be8920-84d2-31bc-e063-6394a90ab438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-03-26
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
742SXX0ICTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
484814Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31f5dc06-50f8-47cf-e063-6294a90ad5fbAvailable on FDA.report

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
71610-896-06Tadalafil6 in 1 BOTTLETABLET62
71610-896-52Tadalafil18 in 1 BOTTLETABLET182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-896TADALAFIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 2 package rows20250503_31f5dc06-50f8-47cf-e063-6294a90ad5fb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLC31f5dc06-50f8-47cf-e063-6294a90ad5fb2025-04-14Warnings, Adverse reactionsExact identifier
ndc (package): 71610-896-52
ndc (product): 71610-896
ndc11 (package): 71610089652

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN31f5dc06-50f8-47cf-e063-6294a90ad5fb2
484814tadalafil 10 MG Oral TabletSCD31f5dc06-50f8-47cf-e063-6294a90ad5fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-896-527161008965218 TABLET in 1 BOTTLE (71610-896-52) 18 tablet2025-04-02NoNoCurrent