Solifenacin Succinate

Product NDC
71205-561
11-digit product format
712050561
Labeler code
71205
Product ID
71205-561_a3a77fb3-af3f-4c6f-be7e-8ce349d2a2cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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

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
71205-561-30Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED302
71205-561-60Solifenacin Succinate60 in 1 BOTTLETABLET, FILM COATED602
71205-561-90Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-561-30EA - Each71205-561d6fd25c2-044f-4204-9e56-89fd77719e7512021-06-02
71205-561-90EA - Each71205-561a2abe12a-1fd7-4c6e-abb8-7155089189bf12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-561SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220604_c67107f4-348b-4a23-a67c-26fd8241ebd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-561-307120505613030 TABLET, FILM COATED in 1 BOTTLE (71205-561-30) 2021-05-070000-00-00NoNoCurrent
71205-561-607120505616060 TABLET, FILM COATED in 1 BOTTLE (71205-561-60) 2021-05-070000-00-00NoNoCurrent
71205-561-907120505619090 TABLET, FILM COATED in 1 BOTTLE (71205-561-90) 2021-05-070000-00-00NoNoCurrent