Darifenacin

Product NDC
72162-2571
11-digit product format
721622571
Labeler code
72162
Product ID
72162-2571_54c987d0-04fd-4fbc-8a3e-6d7c24132e48
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
15 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 HYDROBROMIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCR02EYQ8GV
Rxcui485421

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
72162-2571-3Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2571-3EA - Each72162-2571617029df-101d-4c83-8674-53660195226c12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSN5ac2cb5a-c0bb-40e2-95d5-1b91a13036c3100
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCD5ac2cb5a-c0bb-40e2-95d5-1b91a13036c3100
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSY5ac2cb5a-c0bb-40e2-95d5-1b91a13036c3100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2571-37216225710330 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2571-3) 2025-11-17NoNoCurrent