Solifenacin Succinate

Product NDC
63629-8870
11-digit product format
636298870
Labeler code
63629
Product ID
63629-8870_54e93c57-fe3c-4578-9048-7957281e8e5a
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
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
63629-8870-1Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8870-1EA - Each63629-8870c77c4d11-3832-4fbe-975b-4144777d525c12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8870SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241122_2462e9a4-66a7-4340-9a81-617f3417b495.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN2462e9a4-66a7-4340-9a81-617f3417b495105
477372solifenacin succinate 10 MG Oral TabletSCD2462e9a4-66a7-4340-9a81-617f3417b495105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8870-16362988700190 TABLET, FILM COATED in 1 BOTTLE (63629-8870-1) 2021-09-300000-00-00NoNoCurrent