FDA.reportPublic FDA data

Tadalafil

Product NDC
68788-8292
11-digit product format
687888292
Labeler code
68788
Product ID
68788-8292_0f68ca87-9c30-4ad8-b72f-19ee28d15b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209654
Marketing category
ANDA
Marketing start
2022-11-28
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
68788-8292-1Tadalafil15 in 1 BOTTLETABLET154
68788-8292-2Tadalafil20 in 1 BOTTLETABLET204
68788-8292-3Tadalafil30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8292-1EA - Each68788-829220165e38-9c73-4130-8fc1-8e0ab71a02a312023-01-09
68788-8292-2EA - Each68788-8292c113d333-8b01-4593-9e0b-ddb5cb66c4f112023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8292TADALAFIL TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240816_2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f84
403957tadalafil 5 MG Oral TabletSCD2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8292-16878882920115 TABLET in 1 BOTTLE (68788-8292-1) 15 tablet2022-11-280000-00-00NoNoCurrent
68788-8292-26878882920220 TABLET in 1 BOTTLE (68788-8292-2) 20 tablet2022-11-280000-00-00NoNoCurrent
68788-8292-36878882920330 TABLET in 1 BOTTLE (68788-8292-3) 30 tablet2024-08-15NoNoHistorical