FDA.reportPublic FDA data

Darifenacin

Product NDC
69097-432
11-digit product format
690970432
Labeler code
69097
Product ID
69097-432_99ca2704-b757-4f10-be5c-bd01dff69b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darifenacin Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA207664
Marketing category
ANDA
Marketing start
2016-09-01
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
69097-432-02Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE309
69097-432-05Darifenacin90 in 1 BOTTLETABLET, EXTENDED RELEASE909
69097-432-15Darifenacin1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-432-02EA - Each69097-4322b3bb023-db06-483f-a7dc-c0409b6bd04912016-10-06
69097-432-05EA - Each69097-432f7f89924-c48f-47db-830e-80a10b3902e512016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-432DARIFENACIN (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE [CIPLA USA INC.]8Current NDC, Legacy NDC, 3 package rows20210819_6e8470d1-c3e6-4644-b70a-aa47ddf79676.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSN6e8470d1-c3e6-4644-b70a-aa47ddf796769
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSN6e8470d1-c3e6-4644-b70a-aa47ddf796769
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCD6e8470d1-c3e6-4644-b70a-aa47ddf796769
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCD6e8470d1-c3e6-4644-b70a-aa47ddf796769
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSY6e8470d1-c3e6-4644-b70a-aa47ddf796769
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSY6e8470d1-c3e6-4644-b70a-aa47ddf796769

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-432-026909704320230 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-02) 2016-09-010000-00-00NoNoCurrent
69097-432-056909704320590 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-05) 2016-09-010000-00-00NoNoCurrent
69097-432-15690970432151000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-15) 2016-09-010000-00-00NoNoCurrent