Tadalafil

Product NDC
0093-3019
11-digit product format
000933019
Labeler code
0093
Product ID
0093-3019_08e8069b-c417-4cb8-8423-ffc540232a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090141
Marketing category
ANDA
Marketing start
2018-09-27
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
0093-3019-56EA - Each0093-3019e399b03b-6b23-4f53-8fa6-449409eab94112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3019TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]16Legacy NDC20241211_247ec8fe-e44c-4341-b992-2d6fd6d5f2ba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-3019-560009330195630 TABLET, FILM COATED in 1 BOTTLE (0093-3019-56) 2018-09-270000-00-00NoNoCurrent