Tadalafil

Product NDC
50268-738
11-digit product format
502680738
Labeler code
50268
Product ID
50268-738_df22addc-06e7-9804-e053-2a95a90a6c3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA210069
Marketing category
ANDA
Marketing start
2020-02-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-738-11EA - Each50268-738161c5099-db67-4b9d-81ba-74c2042f65f912020-03-10
50268-738-13EA - Each50268-7384c773f51-e9f5-4cb6-b63e-b862ad83180b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-738TADALAFIL TABLET, FILM COATED [AVPAK]6Legacy NDC20250112_9f7dfabf-40dc-d433-e053-2a95a90ac784.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-738-135026807381330 BLISTER PACK in 1 BOX (50268-738-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-738-11) 30 blister pack2020-02-260000-00-00NoNoCurrent