FDA.reportPublic FDA data

Solifenacin succinate

Product NDC
82804-058
11-digit product format
828040058
Labeler code
82804
Product ID
82804-058_b20003a6-f781-4563-9824-3e8b97c763c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui477372

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-058-30Solifenacin succinate30 in 1 BOTTLETABLET, FILM COATED301
82804-058-60Solifenacin succinate60 in 1 BOTTLETABLET, FILM COATED601
82804-058-90Solifenacin succinate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-058-30EA - Each82804-058aafae8d8-cdef-4546-a8c1-0fa2f969b9ea12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-058SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20240120_b20003a6-f781-4563-9824-3e8b97c763c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
82804-058-308280400583030 TABLET, FILM COATED in 1 BOTTLE (82804-058-30) 2024-01-15NoNoCurrent
82804-058-608280400586060 TABLET, FILM COATED in 1 BOTTLE (82804-058-60) 2024-01-15NoNoCurrent
82804-058-908280400589090 TABLET, FILM COATED in 1 BOTTLE (82804-058-90) 2024-01-15NoNoCurrent