FDA.reportPublic FDA data

Darifenacin

Product NDC
13668-203
11-digit product format
136680203
Labeler code
13668
Product ID
13668-203_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
15 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 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
13668-203-05Darifenacin500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
13668-203-30Darifenacin30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
13668-203-90Darifenacin90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-203-30EA - Each13668-203af4513ad-d333-418d-b49f-2ed9eee22aa812017-08-11
13668-203-90EA - Each13668-2034d8e4012-b84d-4df4-9ed9-bf933934bba212017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-203DARIFENACIN 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
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
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
13668-203-0513668020305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-05) 2016-11-180000-00-00NoNoCurrent
13668-203-301366802033030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-30) 2016-11-180000-00-00NoNoCurrent
13668-203-7413668020374100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-203-74) 2016-11-180000-00-00NoNoCurrent
13668-203-901366802039090 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-90) 2016-11-180000-00-00NoNoCurrent