FDA.reportPublic FDA data

Tadalafil

Product NDC
63629-8288
11-digit product format
636298288
Labeler code
63629
Product ID
63629-8288_08531412-01c1-4053-93b6-83f785a873cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209654
Marketing category
ANDA
Marketing start
2019-03-26
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
63629-8288-1Tadalafil30 in 1 BOTTLETABLET30108
63629-8288-2Tadalafil90 in 1 BOTTLETABLET90108
63629-8288-3Tadalafil15 in 1 BOTTLETABLET15108
63629-8288-4Tadalafil60 in 1 BOTTLETABLET60108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8288-2EA - Each63629-8288382bfc8d-9544-4b8a-a3fe-eca18f748c6812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8288TADALAFIL TABLET [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 4 package rows20240809_185a3284-3a4f-44d3-9278-98581d33f95b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN185a3284-3a4f-44d3-9278-98581d33f95b108
403957tadalafil 5 MG Oral TabletSCD185a3284-3a4f-44d3-9278-98581d33f95b108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8288-16362982880130 TABLET in 1 BOTTLE (63629-8288-1) 30 tablet2022-06-130000-00-00NoNoCurrent
63629-8288-26362982880290 TABLET in 1 BOTTLE (63629-8288-2) 90 tablet2023-03-100000-00-00NoNoCurrent
63629-8288-36362982880315 TABLET in 1 BOTTLE (63629-8288-3) 15 tablet2021-02-22NoNoHistorical
63629-8288-46362982880460 TABLET in 1 BOTTLE (63629-8288-4) 60 tablet2021-02-22NoNoHistorical