Solifenacin Succinate

Product NDC
42291-739
11-digit product format
422910739
Labeler code
42291
Product ID
42291-739_4874ff98-e2e2-226a-e063-6394a90a30f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succiate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA210281
Marketing category
ANDA
Marketing start
2020-10-01
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
42291-739-30Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED304
42291-739-90Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-739SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCIATE) TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [AVKARE]3Current NDC, Legacy NDC, 2 package rows20240111_b0a0651e-1488-36b7-e053-2995a90a3f14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
42291-739-304229107393030 TABLET, FILM COATED in 1 BOTTLE (42291-739-30) 2020-10-010000-00-00NoNoCurrent
42291-739-904229107399090 TABLET, FILM COATED in 1 BOTTLE (42291-739-90) 2020-10-010000-00-00NoNoCurrent