FDA.reportPublic FDA data

Tadalafil

Product NDC
68788-8445
11-digit product format
687888445
Labeler code
68788
Product ID
68788-8445_fb055d56-71ea-4d31-818f-9666d16605d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209654
Marketing category
ANDA
Marketing start
2023-05-15
Substance
TADALAFIL
Active strength
20 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
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019

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
68788-8445-1Tadalafil15 in 1 BOTTLETABLET153
68788-8445-3Tadalafil30 in 1 BOTTLETABLET303
68788-8445-7Tadalafil7 in 1 BOTTLETABLET73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8445-1EA - Each68788-8445dd5ce477-ac9c-474d-a8d1-ffb7940c4c6d12024-11-05
68788-8445-3EA - Each68788-844587428281-e973-4c35-aca0-444fa27c563a12023-07-06
68788-8445-7EA - Each68788-84459424f6fa-66fe-4319-96ea-f11b47d863df12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8445TADALAFIL TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240816_761dc0f8-2f65-4615-ab49-a4bcffd40ce9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN761dc0f8-2f65-4615-ab49-a4bcffd40ce93
402019tadalafil 20 MG Oral TabletSCD761dc0f8-2f65-4615-ab49-a4bcffd40ce93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8445-16878884450115 TABLET in 1 BOTTLE (68788-8445-1) 15 tablet2024-08-15NoNoHistorical
68788-8445-36878884450330 TABLET in 1 BOTTLE (68788-8445-3) 30 tablet2023-05-15NoNoHistorical
68788-8445-7687888445077 TABLET in 1 BOTTLE (68788-8445-7) 7 tablet2024-08-15NoNoHistorical