FDA.reportPublic FDA data

TADALAFIL

Product NDC
71610-908
11-digit product format
716100908
Labeler code
71610
Product ID
71610-908_35a64ceb-88bf-d4ed-e063-6394a90a7799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210609
Marketing category
ANDA
Marketing start
2024-11-27
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-908-04TADALAFIL4 in 1 BOTTLETABLET42
71610-908-06TADALAFIL6 in 1 BOTTLETABLET62
71610-908-12TADALAFIL12 in 1 BOTTLETABLET122
71610-908-39TADALAFIL1440 in 1 BOTTLETABLET14402
71610-908-52TADALAFIL18 in 1 BOTTLETABLET182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-908-04EA - Each71610-9089923484a-2145-49bb-bbd8-bacdca3cd59812025-06-13
71610-908-06EA - Each71610-908ed70b87b-258b-4cee-9050-aa632afcd80f12025-06-13
71610-908-12EA - Each71610-908811619e1-488d-4ea2-9ccc-4d70b82e40da12025-06-13
71610-908-39EA - Each71610-908d02b4398-71da-4ce8-93af-0ffbec3d39a512025-06-13
71610-908-52EA - Each71610-908f991769b-84fc-4614-8580-93a3ada35da412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-908TADALAFIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 5 package rows20250523_351de7c2-98bf-7c88-e063-6294a90ad811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN351de7c2-98bf-7c88-e063-6294a90ad8112
484814tadalafil 10 MG Oral TabletSCD351de7c2-98bf-7c88-e063-6294a90ad8112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-908-04716100908044 TABLET in 1 BOTTLE (71610-908-04) 4 tablet2025-05-16NoNoHistorical
71610-908-06716100908066 TABLET in 1 BOTTLE (71610-908-06) 6 tablet2025-05-16NoNoHistorical
71610-908-127161009081212 TABLET in 1 BOTTLE (71610-908-12) 12 tablet2025-05-16NoNoHistorical
71610-908-39716100908391440 TABLET in 1 BOTTLE (71610-908-39) 1440 tablet2025-05-13NoNoHistorical
71610-908-527161009085218 TABLET in 1 BOTTLE (71610-908-52) 18 tablet2025-05-16NoNoHistorical