Tadalafil

Product NDC
71610-213
11-digit product format
716100213
Labeler code
71610
Product ID
71610-213_004c75b3-29f0-4e32-82fe-fec4ce0350d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021368
Marketing category
NDA AUTHORIZED GENERIC
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-213-04EA - Each71610-21321318b0e-9856-4aac-a724-5d16cdb23f1e12019-02-13
71610-213-12EA - Each71610-21321f7d7f7-eaf4-4846-a964-3a92a4b974b712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-213TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20190110_1621128d-56e9-48f0-876c-77081daa7f12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-213-04716100213044 TABLET, FILM COATED in 1 BOTTLE (71610-213-04) 2018-12-280000-00-00NoNoCurrent
71610-213-127161002131212 TABLET, FILM COATED in 1 BOTTLE (71610-213-12) 2018-12-280000-00-00NoNoCurrent