solifenacin succinate

Product NDC
27241-038
11-digit product format
272410038
Labeler code
27241
Product ID
27241-038_abee70a8-6884-4748-b266-11a84236c0a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA205483
Marketing category
ANDA
Marketing start
2019-05-20
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
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 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
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-038-03solifenacin succinate30 in 1 BOTTLETABLET, FILM COATED308
27241-038-09solifenacin succinate90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-038-03EA - Each27241-038920802fe-af0c-4309-8f4a-06531829d35c12019-06-19
27241-038-09EA - Each27241-0388c8ba725-b850-4f35-ac4e-68ce10ddb91512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-038SOLIFENACIN SUCCINATE TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [AJANTA PHARMA USA INC.]7Current NDC, Legacy NDC, 2 package rows20211123_9558ed7a-e942-4261-8aea-6033352f79b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN9558ed7a-e942-4261-8aea-6033352f79b88
477367solifenacin succinate 5 MG Oral TabletPSN9558ed7a-e942-4261-8aea-6033352f79b88
477372solifenacin succinate 10 MG Oral TabletSCD9558ed7a-e942-4261-8aea-6033352f79b88
477367solifenacin succinate 5 MG Oral TabletSCD9558ed7a-e942-4261-8aea-6033352f79b88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-038-032724100380330 TABLET, FILM COATED in 1 BOTTLE (27241-038-03) 2019-05-200000-00-00NoNoCurrent
27241-038-092724100380990 TABLET, FILM COATED in 1 BOTTLE (27241-038-09) 2019-05-200000-00-00NoNoCurrent