Solifenacin Succinate

Product NDC
67877-527
11-digit product format
678770527
Labeler code
67877
Product ID
67877-527_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
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
67877-527-30Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED309
67877-527-33Solifenacin Succinate10 in 1 BLISTER PACKTABLET, FILM COATED109
67877-527-38Solifenacin Succinate10 in 1 CARTONTABLET, FILM COATED109
67877-527-90Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-527-30EA - Each67877-52760cb3e88-01e3-472c-96ab-b8d127c7da1112019-06-19
67877-527-90EA - Each67877-527717b3bc4-29bb-42db-9da7-96e8bba27e4612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-527SOLIFENACIN 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
477367solifenacin succinate 5 MG Oral TabletPSN2dfc5d69-8f35-4f57-90b7-46a5f0f0febe105
477367solifenacin succinate 5 MG Oral TabletPSN8d65dcb9-aa67-4cfb-9d15-43d0de327bd7105
477367solifenacin succinate 5 MG Oral TabletPSNdadb9462-953e-4319-b9f8-5b7255d1cf9c105
477367solifenacin succinate 5 MG Oral TabletSCD2dfc5d69-8f35-4f57-90b7-46a5f0f0febe105
477367solifenacin succinate 5 MG Oral TabletSCD8d65dcb9-aa67-4cfb-9d15-43d0de327bd7105
477367solifenacin succinate 5 MG Oral TabletSCDdadb9462-953e-4319-b9f8-5b7255d1cf9c105
477367solifenacin succinate 5 MG Oral TabletPSN3788df43-42dd-4778-8289-e32b5844358e103
477367solifenacin succinate 5 MG Oral TabletSCD3788df43-42dd-4778-8289-e32b5844358e103
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
477367solifenacin succinate 5 MG Oral TabletPSNc67107f4-348b-4a23-a67c-26fd8241ebd62
477367solifenacin succinate 5 MG Oral TabletSCDc67107f4-348b-4a23-a67c-26fd8241ebd62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-527-306787705273030 TABLET, FILM COATED in 1 BOTTLE (67877-527-30) 2019-05-210000-00-00NoNoCurrent
67877-527-336787705273310 in 1 BLISTER PACKHistorical
67877-527-386787705273810 BLISTER PACK in 1 CARTON (67877-527-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-527-33) 10 blister pack2019-05-210000-00-00NoNoCurrent
67877-527-906787705279090 TABLET, FILM COATED in 1 BOTTLE (67877-527-90) 2019-05-210000-00-00NoNoCurrent