Solifenacin Succinate

Product NDC
29300-329
11-digit product format
293000329
Labeler code
29300
Product ID
29300-329_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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-329-05Solifenacin Succinate500 in 1 BOTTLETABLET, FILM COATED5006
29300-329-13Solifenacin Succinate30 in 1 BOTTLETABLET, FILM COATED306
29300-329-19Solifenacin Succinate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-329-13EA - Each29300-3295fe33ad2-da87-4630-97ea-b6f4b37b54ab12020-05-08
29300-329-19EA - Each29300-329be839400-7640-410e-8de8-59466950257412020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-329SOLIFENACIN 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
477372solifenacin succinate 10 MG Oral TabletPSN1d8e8f6f-0a59-479f-8415-c5c5f19e19771
477372solifenacin succinate 10 MG Oral TabletSCD1d8e8f6f-0a59-479f-8415-c5c5f19e19771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-329-0529300032905500 TABLET, FILM COATED in 1 BOTTLE (29300-329-05) 2020-03-230000-00-00NoNoCurrent
29300-329-132930003291330 TABLET, FILM COATED in 1 BOTTLE (29300-329-13) 2020-03-230000-00-00NoNoCurrent
29300-329-192930003291990 TABLET, FILM COATED in 1 BOTTLE (29300-329-19) 2020-03-230000-00-00NoNoCurrent