FDA.reportPublic FDA data

Solifenacin Succinate

Product NDC
35561-285
11-digit product format
355610285
Labeler code
35561
Product ID
35561-285_49fcc8a4-31aa-6975-e063-6394a90a9389
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succiate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bostal LLC
Application
ANDA210281
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Solifenacin Succinate
Listing expiration
2027-12-31

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
35561-285-00Solifenacin Succinate256410 in 1 BOXTABLET, FILM COATED25641010
35561-285-10Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED3010
35561-285-11Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED9010
35561-285-13Solifenacin Succinate500 in 1 BOTTLETABLET, FILM COATED50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35561-285-10EA - Each35561-2857005c97d-989b-4776-b3ae-014f994f536f12019-06-19
35561-285-11EA - Each35561-28569ab8f82-4037-4671-8f4d-402b0d3db4b612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35561-285SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCIATE) TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [AUSTARPHARMA LLC]9Current NDC, Legacy NDC, 4 package rows20250331_d155c739-6870-4938-ba91-8c1b4b90afe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSNd155c739-6870-4938-ba91-8c1b4b90afe410
477367solifenacin succinate 5 MG Oral TabletPSNd155c739-6870-4938-ba91-8c1b4b90afe410
477372solifenacin succinate 10 MG Oral TabletSCDd155c739-6870-4938-ba91-8c1b4b90afe410
477367solifenacin succinate 5 MG Oral TabletSCDd155c739-6870-4938-ba91-8c1b4b90afe410
477372solifenacin succinate 10 MG Oral TabletPSNb0a0651e-1488-36b7-e053-2995a90a3f144
477367solifenacin succinate 5 MG Oral TabletPSNb0a0651e-1488-36b7-e053-2995a90a3f144
477372solifenacin succinate 10 MG Oral TabletSCDb0a0651e-1488-36b7-e053-2995a90a3f144
477367solifenacin succinate 5 MG Oral TabletSCDb0a0651e-1488-36b7-e053-2995a90a3f144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35561-285-0035561028500256410 TABLET, FILM COATED in 1 BOX (35561-285-00) 2019-05-20NoNoHistorical
35561-285-103556102851030 TABLET, FILM COATED in 1 BOTTLE (35561-285-10) 2019-05-200000-00-00NoNoCurrent
35561-285-113556102851190 TABLET, FILM COATED in 1 BOTTLE (35561-285-11) 2019-05-200000-00-00NoNoCurrent
35561-285-1335561028513500 TABLET, FILM COATED in 1 BOTTLE (35561-285-13) 2019-05-200000-00-00NoNoCurrent