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

Additional Listing Data#

Finished product
Yes
Brand name base
Darifenacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCR02EYQ8GV
Rxcui485423

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a92d88f6-1aad-c4c8-f6bc-f9f74c3d7bb2Product name720200407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2570-3Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2570-3EA - Each72162-2570b93b9697-a357-474d-98c1-8dfcf90e825112026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSN697eba55-9e1f-4036-baed-5644c810f166100
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCD697eba55-9e1f-4036-baed-5644c810f166100
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSY697eba55-9e1f-4036-baed-5644c810f166100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2570-37216225700330 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2570-3) 2025-11-17NoNoCurrent