FDA.reportPublic FDA data

Darifenacin

Product NDC
69097-431
11-digit product format
690970431
Labeler code
69097
Product ID
69097-431_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
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
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
69097-431-02Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE309
69097-431-05Darifenacin90 in 1 BOTTLETABLET, EXTENDED RELEASE909
69097-431-15Darifenacin1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-431-02EA - Each69097-4311fc20519-b54c-4bef-9021-03894c153d8d12016-10-06
69097-431-05EA - Each69097-4319465968d-d4db-4ad1-84a4-ffdc2f79052812016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-431DARIFENACIN (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
69097-431-026909704310230 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02) 2016-09-010000-00-00NoNoCurrent
69097-431-056909704310590 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05) 2016-09-010000-00-00NoNoCurrent
69097-431-15690970431151000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-15) 2016-09-010000-00-00NoNoCurrent