Solifenacin Succinate

Product NDC
63629-8869
11-digit product format
636298869
Labeler code
63629
Product ID
63629-8869_fc62246b-3427-4e5a-9d12-91ecfd2bb342
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
63629-8869-1Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED30105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8869-1EA - Each63629-88694b6e04a7-d9dd-482c-a669-2b5a2ae978bb12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8869SOLIFENACIN SUCCINATE TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241122_663d992d-23cc-4a8e-acd5-a4bea505ba3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN663d992d-23cc-4a8e-acd5-a4bea505ba3a105
477372solifenacin succinate 10 MG Oral TabletSCD663d992d-23cc-4a8e-acd5-a4bea505ba3a105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8869-16362988690130 TABLET, FILM COATED in 1 BOTTLE (63629-8869-1) 2021-09-300000-00-00NoNoCurrent