VESIcare

Product NDC
51248-250
11-digit product format
512480250
Labeler code
51248
Product ID
51248-250_de0d92da-e334-4032-bbac-d3c8177d4bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA209529
Marketing category
NDA
Marketing start
2020-05-26
Marketing end
2026-07-31
Substance
SOLIFENACIN SUCCINATE
Active strength
1 mg/mL
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VESIcare
Brand name suffix
LS

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKKA5DLD701
Rxcui2375321, 2375325

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
51248-250-99VESIcareLS1 in 1 CARTONSUSPENSION14
51248-250-99VESIcareLS150 mL in 1 BOTTLE, PLASTICSUSPENSION1504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51248-250-99ML - Milliliter51248-2507cb31e2d-4da5-4262-8a2f-6ae4a6c9743512021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51248-250VESICARE LS (SOLIFENACIN SUCCINATE) SUSPENSION [ASTELLAS PHARMA US, INC.]3Current NDC, Legacy NDC, 2 package rows20221223_e0300384-e980-45d5-8ed4-48a2618671ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2375321solifenacin succinate 5 MG in 5 mL Oral SuspensionPSNe0300384-e980-45d5-8ed4-48a2618671ae4
2375325VESIcare LS 5 MG in 5 mL Oral SuspensionPSNe0300384-e980-45d5-8ed4-48a2618671ae4
2375325solifenacin succinate 1 MG/ML Oral Suspension [Vesicare]SBDe0300384-e980-45d5-8ed4-48a2618671ae4
2375321solifenacin succinate 1 MG/ML Oral SuspensionSCDe0300384-e980-45d5-8ed4-48a2618671ae4
2375321solifenacin succinate 5 MG per 5 ML Oral SuspensionSYe0300384-e980-45d5-8ed4-48a2618671ae4
2375325Vesicare 1 MG/ML Oral SuspensionSYe0300384-e980-45d5-8ed4-48a2618671ae4
2375325Vesicare LS 5 MG per 5 ML Oral SuspensionSYe0300384-e980-45d5-8ed4-48a2618671ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51248-250-99512480250991 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC2020-05-262026-07-31NoNoCurrent