Darifenacin

Product NDC
72162-2570
11-digit product format
721622570
Labeler code
72162
Product ID
72162-2570_2a6e97d9-19e4-42aa-86e8-27bab91f059d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darifenacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205209
Marketing category
ANDA
Marketing start
2016-11-18
Substance
DARIFENACIN HYDROBROMIDE
Active strength
7.5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CR02EYQ8GVDARIFENACIN HYDROBROMIDE133099-07-7DARIFENACIN HYDROBROMIDE
APG9819VLMDARIFENACIN133099-04-4Darifenacin

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2570-37216225700330 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2570-3) 2025-11-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DarifenacinBryant Ranch Prepack2025-11-17HUMAN PRESCRIPTION DRUG LABEL100