VESIcare

Product NDC
51248-150
11-digit product format
512480150
Labeler code
51248
Product ID
51248-150_5de8c6b0-8a05-4b69-ae10-ffc7ddd286e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacin succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Astellas Pharma US, Inc.
Application
NDA021518
Marketing category
NDA
Marketing start
2005-01-05
Marketing end
2026-08-31
Substance
SOLIFENACIN SUCCINATE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021518-001VESICARESOLIFENACIN SUCCINATE5MGTABLET / ORALRLD2004-11-19
N021518-002VESICARESOLIFENACIN SUCCINATE10MGTABLET / ORALRLD2004-11-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021518-001VESICARE5MGTABLET / ORALRLD2004-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021518-002VESICARE10MGTABLET / ORALRLD2004-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021518-001VESICARE5MGTABLET / ORALABRLD2004-11-19782e0a99824c…
2021-12-28 21:50 UTC2021-12N021518-002VESICARE10MGTABLET / ORALABRLD, RS2004-11-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021518-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021518-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021518-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021518-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021518-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021518-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021518-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021518-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021518-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021518-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021518-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021518-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021518-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021518-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021518-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021518-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021518-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021518-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021518-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021518-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021518-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021518-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021518-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021518-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021518-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021518-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021518-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021518-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021518-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021518-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021518-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021518-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021518-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021518-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021518-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021518-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021518-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021518-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021518-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021518-002AB187673890dc5c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021518-0016017927*PED2019-05-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021518-0026017927*PED2019-05-19Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021518-0016017927*PED2019-05-19Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021518-0026017927*PED2019-05-19Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021518-0016017927*PED2019-05-19Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021518-0026017927*PED2019-05-19Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021518-0016017927*PED2019-05-19Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021518-0026017927*PED2019-05-19Pediatric extensionea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
VESIcare

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLIFENACIN SUCCINATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KKA5DLD701Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477367Internal RxNorm lookup
477372Internal RxNorm lookup
539815Internal RxNorm lookup
539817Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9acee910-cdb2-4052-b8b3-c26aff1c8716Available on FDA.report

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
51248-150-01VESIcare30 in 1 BOTTLETABLET, FILM COATED3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51248-150-01EA - Each51248-1502f11fd9d-9b07-4d5f-9c34-0ff260c11c8512012-07-24
51248-150-03EA - Each51248-15024d1307c-b722-4a1c-8197-8b9b098b7ddd12012-07-24
51248-150-52EA - Each51248-1504bc68dce-d55b-438b-81b5-32b0313f0e4012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51248-150VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [ASTELLAS PHARMA US, INC.]29Current NDC, Legacy NDC, 1 package rows20230511_9acee910-cdb2-4052-b8b3-c26aff1c8716.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VESIcareSOLIFENACIN SUCCINATEAstellas Pharma US, Inc.9acee910-cdb2-4052-b8b3-c26aff1c87162022-10-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021518
application number: NDA021518
ndc (product): 51248-150

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477372solifenacin succinate 10 MG Oral TabletPSN9acee910-cdb2-4052-b8b3-c26aff1c871630
477367solifenacin succinate 5 MG Oral TabletPSN9acee910-cdb2-4052-b8b3-c26aff1c871630
539815VESICARE 10 MG Oral TabletPSN9acee910-cdb2-4052-b8b3-c26aff1c871630
539817VESICARE 5 MG Oral TabletPSN9acee910-cdb2-4052-b8b3-c26aff1c871630
539815solifenacin succinate 10 MG Oral Tablet [Vesicare]SBD9acee910-cdb2-4052-b8b3-c26aff1c871630
539817solifenacin succinate 5 MG Oral Tablet [Vesicare]SBD9acee910-cdb2-4052-b8b3-c26aff1c871630
477372solifenacin succinate 10 MG Oral TabletSCD9acee910-cdb2-4052-b8b3-c26aff1c871630
477367solifenacin succinate 5 MG Oral TabletSCD9acee910-cdb2-4052-b8b3-c26aff1c871630
539815VESIcare 10 MG Oral TabletSY9acee910-cdb2-4052-b8b3-c26aff1c871630
539817VESIcare 5 MG Oral TabletSY9acee910-cdb2-4052-b8b3-c26aff1c871630
477372solifenacin succinate 10 MG Oral TabletPSNe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
477367solifenacin succinate 5 MG Oral TabletPSNe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
477367solifenacin succinate 5 MG Oral TabletPSN100678f1-313a-4e99-ae77-319c610a830f2
539815VESICARE 10 MG Oral TabletPSNe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
539817VESICARE 5 MG Oral TabletPSNe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
539817VESICARE 5 MG Oral TabletPSN100678f1-313a-4e99-ae77-319c610a830f2
539815solifenacin succinate 10 MG Oral Tablet [Vesicare]SBDe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
539817solifenacin succinate 5 MG Oral Tablet [Vesicare]SBD100678f1-313a-4e99-ae77-319c610a830f2
539817solifenacin succinate 5 MG Oral Tablet [Vesicare]SBDe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
477372solifenacin succinate 10 MG Oral TabletSCDe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
477367solifenacin succinate 5 MG Oral TabletSCDe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
477367solifenacin succinate 5 MG Oral TabletSCD100678f1-313a-4e99-ae77-319c610a830f2
539815VESIcare 10 MG Oral TabletSYe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
539817VESIcare 5 MG Oral TabletSYe433dc68-6b2a-4c48-beae-4ec946f1ff1e2
539817VESIcare 5 MG Oral TabletSY100678f1-313a-4e99-ae77-319c610a830f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51248-150-015124801500130 TABLET, FILM COATED in 1 BOTTLE (51248-150-01) 2005-01-052026-08-31NoNoCurrent
51248-150-035124801500390 TABLET, FILM COATED in 1 BOTTLE (51248-150-03) 2005-01-050000-00-00NoNoCurrent
51248-150-5251248015052100 TABLET, FILM COATED in 1 BLISTER PACK (51248-150-52) 2005-01-050000-00-00NoNoCurrent