Tadalafil

Product NDC
71205-502
11-digit product format
712050502
Labeler code
71205
Product ID
71205-502_081d1edf-21a6-4852-bae3-7b285a0f6441
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209167
Marketing category
ANDA
Marketing start
2020-04-03
Substance
TADALAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
742SXX0ICTTADALAFIL171596-29-5TADALAFIL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-502-107120505021010 TABLET, FILM COATED in 1 BOTTLE (71205-502-10) 2020-11-11NoNoHistorical
71205-502-157120505021515 TABLET, FILM COATED in 1 BOTTLE (71205-502-15) 2021-06-10NoNoHistorical
71205-502-307120505023030 TABLET, FILM COATED in 1 BOTTLE (71205-502-30) 2020-11-11NoNoHistorical
71205-502-607120505026060 TABLET, FILM COATED in 1 BOTTLE (71205-502-60) 2020-11-11NoNoHistorical
71205-502-907120505029090 TABLET, FILM COATED in 1 BOTTLE (71205-502-90) 2020-11-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TadalafilProficient Rx LP2022-05-01HUMAN PRESCRIPTION DRUG LABEL3