FDA.reportPublic FDA data

Solifenacin Succinate

Product NDC
65862-879
11-digit product format
658620879
Labeler code
65862
Product ID
65862-879_ececaabb-2b01-4ef5-b5e8-a927478deccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206817
Marketing category
ANDA
Marketing start
2022-12-27
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
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
65862-879-03Solifenacin Succinate3 in 1 CARTONTABLET, FILM COATED33
65862-879-10Solifenacin Succinate10 in 1 BLISTER PACKTABLET, FILM COATED103
65862-879-30Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED303
65862-879-90Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED903
65862-879-99Solifenacin Succinate1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-879-30EA - Each65862-8799f739f7e-4358-4240-8b1a-0c9786f5668c12023-05-05
65862-879-90EA - Each65862-879d2888e5f-8fc2-4180-8f91-0fe375febead12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-879SOLIFENACIN SUCCINATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]3Current NDC, Legacy NDC, 5 package rows20240510_92b37f2d-b1cf-49e6-a13b-0ead92c0604c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN92b37f2d-b1cf-49e6-a13b-0ead92c0604c3
477367solifenacin succinate 5 MG Oral TabletPSN92b37f2d-b1cf-49e6-a13b-0ead92c0604c3
477372solifenacin succinate 10 MG Oral TabletSCD92b37f2d-b1cf-49e6-a13b-0ead92c0604c3
477367solifenacin succinate 5 MG Oral TabletSCD92b37f2d-b1cf-49e6-a13b-0ead92c0604c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-879-03658620879033 BLISTER PACK in 1 CARTON (65862-879-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-879-10) 3 blister pack2022-12-270000-00-00NoNoCurrent
65862-879-106586208791010 in 1 BLISTER PACKHistorical
65862-879-306586208793030 TABLET, FILM COATED in 1 BOTTLE (65862-879-30) 2022-12-270000-00-00NoNoCurrent
65862-879-906586208799090 TABLET, FILM COATED in 1 BOTTLE (65862-879-90) 2022-12-270000-00-00NoNoCurrent
65862-879-99658620879991000 TABLET, FILM COATED in 1 BOTTLE (65862-879-99) 2022-12-270000-00-00NoNoCurrent