Solifenacin Succinate

Product NDC
72205-020
11-digit product format
722050020
Labeler code
72205
Product ID
72205-020_eaccb7fc-2098-43d1-a64e-759b8d4c35c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA210688
Marketing category
ANDA
Marketing start
2019-05-20
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, 477372

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
72205-020-30Solifenacin Succinate30 in 1 BOTTLETABLET303
72205-020-90Solifenacin Succinate90 in 1 BOTTLETABLET903
72205-020-99Solifenacin Succinate1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-020-30EA - Each72205-020754a64c2-8aad-4703-a02d-5bf3fd1fb9dc12019-06-19
72205-020-90EA - Each72205-0202fa49fb7-a80c-4ed6-9efc-307674f656f112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-020SOLIFENACIN SUCCINATE TABLET [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 3 package rows20210715_98b99a4c-201d-46ee-b78c-7634a64d3a8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN98b99a4c-201d-46ee-b78c-7634a64d3a8d3
477367solifenacin succinate 5 MG Oral TabletPSN98b99a4c-201d-46ee-b78c-7634a64d3a8d3
477372solifenacin succinate 10 MG Oral TabletSCD98b99a4c-201d-46ee-b78c-7634a64d3a8d3
477367solifenacin succinate 5 MG Oral TabletSCD98b99a4c-201d-46ee-b78c-7634a64d3a8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-020-307220500203030 TABLET in 1 BOTTLE (72205-020-30) 30 tablet2019-05-200000-00-00NoNoCurrent
72205-020-907220500209090 TABLET in 1 BOTTLE (72205-020-90) 90 tablet2019-05-200000-00-00NoNoCurrent
72205-020-99722050020991000 TABLET in 1 BOTTLE (72205-020-99) 1000 tablet2019-05-200000-00-00NoNoCurrent