FDA.reportPublic FDA data

Darifenacin

Product NDC
13668-202
11-digit product format
136680202
Labeler code
13668
Product ID
13668-202_fe809224-0deb-4a82-b454-054be6dd4931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darifenacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Darifenacin
Listing expiration
2027-12-31

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
13668-202-05Darifenacin500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
13668-202-30Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
13668-202-90Darifenacin90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-202-30EA - Each13668-20205d83bff-c2f1-4456-be87-7a52afcba0e312017-08-11
13668-202-90EA - Each13668-202729df6fa-c45f-43f7-a13e-dda961c823de12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-202DARIFENACIN TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 3 package rows20250426_e84f1ae3-b9a2-4a15-a299-c75373891cc1.zip

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
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSNe84f1ae3-b9a2-4a15-a299-c75373891cc110
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSNe84f1ae3-b9a2-4a15-a299-c75373891cc110
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCDe84f1ae3-b9a2-4a15-a299-c75373891cc110
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCDe84f1ae3-b9a2-4a15-a299-c75373891cc110
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSYe84f1ae3-b9a2-4a15-a299-c75373891cc110
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSYe84f1ae3-b9a2-4a15-a299-c75373891cc110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-202-0513668020205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05) 2016-11-180000-00-00NoNoCurrent
13668-202-301366802023030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30) 2016-11-180000-00-00NoNoCurrent
13668-202-7413668020274100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-202-74) 2016-11-180000-00-00NoNoCurrent
13668-202-901366802029090 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-90) 2016-11-180000-00-00NoNoCurrent