solifenacin succinate

Product NDC
31722-028
11-digit product format
317220028
Labeler code
31722
Product ID
31722-028_e52cdf06-9178-ab2f-e053-2a95a90af2b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215761
Marketing category
ANDA
Marketing start
2022-06-15
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
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-028-30solifenacin succinate30 in 1 BOTTLETABLET, FILM COATED301
31722-028-31solifenacin succinate10 in 1 CARTONTABLET, FILM COATED101
31722-028-32solifenacin succinate10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-028-90solifenacin succinate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-028-30EA - Each31722-028c3ff1bdb-362c-4c58-ae49-9550bc04dd2012022-10-06
31722-028-90EA - Each31722-0282af8cc90-866e-4c91-91d4-fc7994a41d3a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-028SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 4 package rows20220802_6479d24f-373e-4c9e-abaf-349f90a2bbb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN6479d24f-373e-4c9e-abaf-349f90a2bbb11
477367solifenacin succinate 5 MG Oral TabletPSN6479d24f-373e-4c9e-abaf-349f90a2bbb11
477372solifenacin succinate 10 MG Oral TabletSCD6479d24f-373e-4c9e-abaf-349f90a2bbb11
477367solifenacin succinate 5 MG Oral TabletSCD6479d24f-373e-4c9e-abaf-349f90a2bbb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-028-303172200283030 TABLET, FILM COATED in 1 BOTTLE (31722-028-30) 2022-06-150000-00-00NoNoCurrent
31722-028-313172200283110 BLISTER PACK in 1 CARTON (31722-028-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-028-32) 10 blister pack2022-06-150000-00-00NoNoCurrent
31722-028-323172200283210 in 1 BLISTER PACKHistorical
31722-028-903172200289090 TABLET, FILM COATED in 1 BOTTLE (31722-028-90) 2022-06-150000-00-00NoNoCurrent