Solifenacin Succinate

Product NDC
63629-8867
11-digit product format
636298867
Labeler code
63629
Product ID
63629-8867_0cc29a58-4961-4c78-94cf-330f22b28ba4
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
63629-8867-1Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED30105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8867-1EA - Each63629-8867e39913d9-0256-4f6d-8165-7b20f374e0cf12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8867SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240915_2dfc5d69-8f35-4f57-90b7-46a5f0f0febe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477367solifenacin succinate 5 MG Oral TabletPSN2dfc5d69-8f35-4f57-90b7-46a5f0f0febe105
477367solifenacin succinate 5 MG Oral TabletSCD2dfc5d69-8f35-4f57-90b7-46a5f0f0febe105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8867-16362988670130 TABLET, FILM COATED in 1 BOTTLE (63629-8867-1) 2021-09-300000-00-00NoNoCurrent