Solifenacin Succinate

Product NDC
63629-8868
11-digit product format
636298868
Labeler code
63629
Product ID
63629-8868_43806415-3afe-452f-8c9f-3f029c0f82ca
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
63629-8868-1Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8868-1EA - Each63629-886806cdd50c-6ef4-4ed2-8040-9cef622042fc12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8868SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241128_8d65dcb9-aa67-4cfb-9d15-43d0de327bd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477367solifenacin succinate 5 MG Oral TabletPSN8d65dcb9-aa67-4cfb-9d15-43d0de327bd7105
477367solifenacin succinate 5 MG Oral TabletSCD8d65dcb9-aa67-4cfb-9d15-43d0de327bd7105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8868-16362988680190 TABLET, FILM COATED in 1 BOTTLE (63629-8868-1) 2021-09-300000-00-00NoNoCurrent