Solifenacin Succinate

Product NDC
29300-328
11-digit product format
293000328
Labeler code
29300
Product ID
29300-328_82c150d9-febf-4425-bf85-0e4586ae1741
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA211701
Marketing category
ANDA
Marketing start
2020-03-23
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
29300-328-05Solifenacin Succinate500 in 1 BOTTLETABLET, FILM COATED5006
29300-328-13Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED306
29300-328-19Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-328SOLIFENACIN SUCCINATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]6Current NDC, Legacy NDC, 3 package rows20211023_51ff19b4-09ac-4796-8869-671ddd62c578.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN51ff19b4-09ac-4796-8869-671ddd62c5786
477367solifenacin succinate 5 MG Oral TabletPSN51ff19b4-09ac-4796-8869-671ddd62c5786
477372solifenacin succinate 10 MG Oral TabletSCD51ff19b4-09ac-4796-8869-671ddd62c5786
477367solifenacin succinate 5 MG Oral TabletSCD51ff19b4-09ac-4796-8869-671ddd62c5786
477367solifenacin succinate 5 MG Oral TabletPSN8ab4f222-018f-40fc-a6aa-39dab563a8a01
477367solifenacin succinate 5 MG Oral TabletSCD8ab4f222-018f-40fc-a6aa-39dab563a8a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-328-0529300032805500 TABLET, FILM COATED in 1 BOTTLE (29300-328-05) 2020-03-230000-00-00NoNoCurrent
29300-328-132930003281330 TABLET, FILM COATED in 1 BOTTLE (29300-328-13) 2020-03-230000-00-00NoNoCurrent
29300-328-192930003281990 TABLET, FILM COATED in 1 BOTTLE (29300-328-19) 2020-03-230000-00-00NoNoCurrent