FDA.reportPublic FDA data

Darifenacin

Product NDC
16571-768
11-digit product format
165710768
Labeler code
16571
Product ID
16571-768_fd55c56a-79a8-4830-92d7-19f62bee0b5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darifenacin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206743
Marketing category
ANDA
Marketing start
2016-09-19
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
16571-768-03Darifenacin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
16571-768-09Darifenacin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-768-03EA - Each16571-768cc0f51a4-8dc0-479d-8d15-0f0054f6bfa512022-03-09
16571-768-09EA - Each16571-768c1847660-4920-4e29-889a-7b3ac3a0309112022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-768DARIFENACIN TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 2 package rows20240501_e2aa9544-0136-463d-a73b-1a299534446a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSNe2aa9544-0136-463d-a73b-1a299534446a2
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSNe2aa9544-0136-463d-a73b-1a299534446a2
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCDe2aa9544-0136-463d-a73b-1a299534446a2
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCDe2aa9544-0136-463d-a73b-1a299534446a2
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSYe2aa9544-0136-463d-a73b-1a299534446a2
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSYe2aa9544-0136-463d-a73b-1a299534446a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-768-031657107680330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-03) 2016-09-190000-00-00NoNoCurrent
16571-768-091657107680990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09) 2016-09-190000-00-00NoNoCurrent