Solifenacin Succinate

Product NDC
72162-1848
11-digit product format
721621848
Labeler code
72162
Product ID
72162-1848_a5c403f0-a749-471b-a5ba-2c9f9a7ed0b5
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
72162-1848-3Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED30103
72162-1848-9Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1848-3EA - Each72162-18489a9e888a-0779-4eff-823b-9b340694e84612024-04-05
72162-1848-9EA - Each72162-1848ea14e161-64d1-485f-becf-b65c0279d9bd12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1848SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240601_3788df43-42dd-4778-8289-e32b5844358e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477367solifenacin succinate 5 MG Oral TabletPSN3788df43-42dd-4778-8289-e32b5844358e103
477367solifenacin succinate 5 MG Oral TabletSCD3788df43-42dd-4778-8289-e32b5844358e103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1848-37216218480330 TABLET, FILM COATED in 1 BOTTLE (72162-1848-3) 2019-05-21NoNoHistorical
72162-1848-97216218480990 TABLET, FILM COATED in 1 BOTTLE (72162-1848-9) 2019-05-21NoNoHistorical