Solifenacin Succinate

Product NDC
71335-1729
11-digit product format
713351729
Labeler code
71335
Product ID
71335-1729_bd308409-bed0-4fcd-bed6-2b173a86d829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210224
Marketing category
ANDA
Marketing start
2019-05-21
Substance
SOLIFENACIN SUCCINATE
Active strength
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
Solifenacin Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKKA5DLD701
Rxcui477367

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
71335-1729-1Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED30105
71335-1729-2Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED90105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1729SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240602_dadb9462-953e-4319-b9f8-5b7255d1cf9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477367solifenacin succinate 5 MG Oral TabletPSNdadb9462-953e-4319-b9f8-5b7255d1cf9c105
477367solifenacin succinate 5 MG Oral TabletSCDdadb9462-953e-4319-b9f8-5b7255d1cf9c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1729-17133517290130 TABLET, FILM COATED in 1 BOTTLE (71335-1729-1) 2021-09-230000-00-00NoNoCurrent
71335-1729-27133517290290 TABLET, FILM COATED in 1 BOTTLE (71335-1729-2) 2024-05-300000-00-00NoNoCurrent