Solifenacin Succinate

Product NDC
71205-583
11-digit product format
712050583
Labeler code
71205
Product ID
71205-583_585474af-65d8-4ed1-9793-8439d80212fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Solifenacin Succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209333
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
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efc179d5-753a-8dcd-90d4-5676a1c31ce3Product name720250423
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1ddProduct name120201030

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-583-307120505833030 TABLET, FILM COATED in 1 BOTTLE (71205-583-30) 2021-06-250000-00-00NoNoCurrent
71205-583-607120505836060 TABLET, FILM COATED in 1 BOTTLE (71205-583-60) 2021-06-250000-00-00NoNoCurrent
71205-583-907120505839090 TABLET, FILM COATED in 1 BOTTLE (71205-583-90) 2021-06-250000-00-00NoNoCurrent