Tadalafil

Product NDC
50268-739
11-digit product format
502680739
Labeler code
50268
Product ID
50268-739_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
2020-03-18
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 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
50268-739-11EA - Each50268-739a690cb29-b233-432f-b8a3-3ffe21b1e72812020-04-20
50268-739-13EA - Each50268-73953df31e9-314f-4517-aa29-20275486ff7a12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-739TADALAFIL 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
50268-739-135026807391330 BLISTER PACK in 1 BOX (50268-739-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-739-11) 30 blister pack2020-03-180000-00-00NoNoCurrent