Tadalafil

Product NDC
71610-214
11-digit product format
716100214
Labeler code
71610
Product ID
71610-214_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
5 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
71610-214-08EA - Each71610-2140a08f281-a279-46f9-bee8-542e56b88a5712019-02-13
71610-214-11EA - Each71610-214a9ac93fd-95e3-499c-915c-754690eaaec112019-02-13
71610-214-18EA - Each71610-2149760ce76-4840-428a-ac5f-edca494d9fd412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-214TADALAFIL 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
71610-214-08716100214088 TABLET, FILM COATED in 1 BOTTLE (71610-214-08) 2018-12-280000-00-00NoNoCurrent
71610-214-117161002141148 TABLET, FILM COATED in 1 BOTTLE (71610-214-11) 2018-12-280000-00-00NoNoCurrent
71610-214-187161002141816 TABLET, FILM COATED in 1 BOTTLE (71610-214-18) 2018-12-280000-00-00NoNoCurrent