FDA.reportPublic FDA data

Solifenacin succinate

Product NDC
0591-3796
11-digit product format
005913796
Labeler code
0591
Product ID
0591-3796_4a8ad4ea-e579-4269-b16d-fdc627ba1114
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA202551
Marketing category
ANDA
Marketing start
2020-04-09
Substance
SOLIFENACIN SUCCINATE
Active strength
10 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
Solifenacin succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKKA5DLD701
Rxcui477367, 477372

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3796-19Solifenacin succinate90 in 1 BOTTLETABLET, FILM COATED9017
0591-3796-30Solifenacin succinate30 in 1 BOTTLETABLET, FILM COATED3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3796-19EA - Each0591-3796b16faa60-0775-484a-8255-ba82a425c06312020-05-08
0591-3796-30EA - Each0591-3796c53a321b-8ba5-48df-b0ba-7fd59a89960912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3796SOLIFENACIN SUCCINATE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 2 package rows20250417_02e2aa54-1ed8-445a-a082-ac2c64b339fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN02e2aa54-1ed8-445a-a082-ac2c64b339fe17
477367solifenacin succinate 5 MG Oral TabletPSN02e2aa54-1ed8-445a-a082-ac2c64b339fe17
477372solifenacin succinate 10 MG Oral TabletSCD02e2aa54-1ed8-445a-a082-ac2c64b339fe17
477367solifenacin succinate 5 MG Oral TabletSCD02e2aa54-1ed8-445a-a082-ac2c64b339fe17
477372solifenacin succinate 10 MG Oral TabletPSNb20003a6-f781-4563-9824-3e8b97c763c61
477372solifenacin succinate 10 MG Oral TabletSCDb20003a6-f781-4563-9824-3e8b97c763c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3796-190059137961990 TABLET, FILM COATED in 1 BOTTLE (0591-3796-19) 2020-04-090000-00-00NoNoCurrent
0591-3796-300059137963030 TABLET, FILM COATED in 1 BOTTLE (0591-3796-30) 2023-01-23NoNoHistorical