Tadalafil

Product NDC
71205-400
11-digit product format
712050400
Labeler code
71205
Product ID
71205-400_31aa3327-24b2-47cd-a16e-e0727616bc2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210420
Marketing category
ANDA
Marketing start
2019-03-26
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-400-10EA - Each71205-400945bda37-5f6c-40b6-ae6d-63cd37fdef9412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-400TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]1Legacy NDC20200222_31aa3327-24b2-47cd-a16e-e0727616bc2f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-400-107120504001010 TABLET, FILM COATED in 1 BOTTLE (71205-400-10) 2020-02-070000-00-00NoNoCurrent