FDA.reportPublic FDA data

Darifenacin

Product NDC
65862-861
11-digit product format
658620861
Labeler code
65862
Product ID
65862-861_389b20f0-64d5-46f6-bb3b-74feb1a9898b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darifenacin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206743
Marketing category
ANDA
Marketing start
2016-09-19
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
65862-861-05Darifenacin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005
65862-861-30Darifenacin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
65862-861-90Darifenacin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905
65862-861-99Darifenacin1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-861-30EA - Each65862-8613a3b6135-1cdb-4eea-93d9-7123c6ddbd2f12016-10-06
65862-861-90EA - Each65862-861cada1438-34ab-49cc-987b-4f9af66c1a5612016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-861DARIFENACIN TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]5Current NDC, Legacy NDC, 4 package rows20240426_28ed5b58-46dd-4140-a877-4b422f780a94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSN28ed5b58-46dd-4140-a877-4b422f780a945
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSN28ed5b58-46dd-4140-a877-4b422f780a945
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCD28ed5b58-46dd-4140-a877-4b422f780a945
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCD28ed5b58-46dd-4140-a877-4b422f780a945
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSY28ed5b58-46dd-4140-a877-4b422f780a945
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSY28ed5b58-46dd-4140-a877-4b422f780a945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-861-0565862086105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-05) 2016-09-190000-00-00NoNoCurrent
65862-861-306586208613030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-30) 2016-09-190000-00-00NoNoCurrent
65862-861-906586208619090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-90) 2016-09-190000-00-00NoNoCurrent
65862-861-99658620861991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-99) 2016-09-190000-00-00NoNoCurrent