FDA.reportPublic FDA data

Solifenacin Succinate

Product NDC
67877-528
11-digit product format
678770528
Labeler code
67877
Product ID
67877-528_e0e2cc86-60c8-450a-86f8-c551308ff027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
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
67877-528-30Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED309
67877-528-33Solifenacin Succinate10 in 1 BLISTER PACKTABLET, FILM COATED109
67877-528-38Solifenacin Succinate10 in 1 CARTONTABLET, FILM COATED109
67877-528-90Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-528-30EA - Each67877-528ef678064-9dd8-4cce-9c0f-8561374022d812019-06-19
67877-528-90EA - Each67877-528b5790ad0-36fc-4685-ada6-254cee69ac1d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-528SOLIFENACIN SUCCINATE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 4 package rows20240521_97d8a21e-4618-460f-8cf5-97a9d946039e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN2462e9a4-66a7-4340-9a81-617f3417b495105
477372solifenacin succinate 10 MG Oral TabletPSN663d992d-23cc-4a8e-acd5-a4bea505ba3a105
477372solifenacin succinate 10 MG Oral TabletSCD2462e9a4-66a7-4340-9a81-617f3417b495105
477372solifenacin succinate 10 MG Oral TabletSCD663d992d-23cc-4a8e-acd5-a4bea505ba3a105
477372solifenacin succinate 10 MG Oral TabletPSNe04812c2-2ff7-4dff-9122-518c18f4935e102
477372solifenacin succinate 10 MG Oral TabletSCDe04812c2-2ff7-4dff-9122-518c18f4935e102
477372solifenacin succinate 10 MG Oral TabletPSNf0b8f111-1d76-4b04-9e2f-9fca9e5a0b00100
477372solifenacin succinate 10 MG Oral TabletSCDf0b8f111-1d76-4b04-9e2f-9fca9e5a0b00100
477372solifenacin succinate 10 MG Oral TabletPSN97d8a21e-4618-460f-8cf5-97a9d946039e9
477367solifenacin succinate 5 MG Oral TabletPSN97d8a21e-4618-460f-8cf5-97a9d946039e9
477372solifenacin succinate 10 MG Oral TabletSCD97d8a21e-4618-460f-8cf5-97a9d946039e9
477367solifenacin succinate 5 MG Oral TabletSCD97d8a21e-4618-460f-8cf5-97a9d946039e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-528-306787705283030 TABLET, FILM COATED in 1 BOTTLE (67877-528-30) 2019-05-210000-00-00NoNoCurrent
67877-528-336787705283310 in 1 BLISTER PACKHistorical
67877-528-386787705283810 BLISTER PACK in 1 CARTON (67877-528-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-528-33) 10 blister pack2019-05-210000-00-00NoNoCurrent
67877-528-906787705289090 TABLET, FILM COATED in 1 BOTTLE (67877-528-90) 2019-05-210000-00-00NoNoCurrent