FDA.reportPublic FDA data

Darifenacin

Product NDC
52605-068
11-digit product format
526050068
Labeler code
52605
Product ID
52605-068_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darifenacin Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
POLYGEN PHARMACEUTICALS INC.
Application
ANDA211045
Marketing category
ANDA
Marketing start
2020-12-01
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, 485423

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
52605-068-10Darifenacin1000 in 1 BOTTLETABLET, EXTENDED RELEASE10003
52605-068-13Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE303
52605-068-19Darifenacin90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-068DARIFENACIN (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE [POLYGEN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20221214_62a72d3e-3c33-4f2d-b3d0-2e014f704c63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSN62a72d3e-3c33-4f2d-b3d0-2e014f704c633
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSN62a72d3e-3c33-4f2d-b3d0-2e014f704c633
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCD62a72d3e-3c33-4f2d-b3d0-2e014f704c633
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCD62a72d3e-3c33-4f2d-b3d0-2e014f704c633
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSY62a72d3e-3c33-4f2d-b3d0-2e014f704c633
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSY62a72d3e-3c33-4f2d-b3d0-2e014f704c633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52605-068-10526050068101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-10) 2020-12-010000-00-00NoNoCurrent
52605-068-135260500681330 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13) 2020-12-010000-00-00NoNoCurrent
52605-068-195260500681990 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-19) 2020-12-010000-00-00NoNoCurrent