Home NDC 51248-151 VESIcare
Product NDC 51248-151
11-digit product format 512480151
Labeler code 51248
Product ID 51248-151_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 10 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021518-001 VESICARE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL RLD 2004-11-19 N021518-002 VESICARE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL RLD 2004-11-19
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021518-001 VESICARE 5MG TABLET / ORAL RLD 2004-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021518-002 VESICARE 10MG TABLET / ORAL RLD 2004-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021518-001 VESICARE 5MG TABLET / ORAL AB RLD 2004-11-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021518-002 VESICARE 10MG TABLET / ORAL AB RLD, RS 2004-11-19 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021518-001 6017927*PED 2019-05-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021518-002 6017927*PED 2019-05-19 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021518-001 6017927*PED 2019-05-19 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021518-002 6017927*PED 2019-05-19 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021518-001 6017927*PED 2019-05-19 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021518-002 6017927*PED 2019-05-19 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021518-001 6017927*PED 2019-05-19 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021518-002 6017927*PED 2019-05-19 Pediatric extension ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base VESIcare Active Ingredients# Ingredient, Strength table Ingredient Strength SOLIFENACIN SUCCINATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KKA5DLD701 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 477367 Internal RxNorm lookup 477372 Internal RxNorm lookup 539815 Internal RxNorm lookup 539817 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51248-151-01 VESIcare 30 in 1 BOTTLE TABLET, FILM COATED 30 30 51248-151-03 VESIcare 90 in 1 BOTTLE TABLET, FILM COATED 90 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SOLIFENACIN SUCCINATE ACTIVE INGREDIENT KKA5DLD701 VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [ASTELLAS PHARMA TECHNOLOGIES, INC.] 20 SOLIFENACIN ACTIVE MOIETY A8910SQJ1U VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [ASTELLAS PHARMA TECHNOLOGIES, INC.] 20 SOLIFENACIN SUCCINATE ACTIVE INGREDIENT KKA5DLD701 VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [CARDINAL HEALTH] 8 SOLIFENACIN ACTIVE MOIETY A8910SQJ1U VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [CARDINAL HEALTH] 8 SOLIFENACIN SUCCINATE ACTIVE INGREDIENT KKA5DLD701 VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [CARDINAL HEALTH] 2 SOLIFENACIN SUCCINATE ACTIVE INGREDIENT KKA5DLD701 VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SOLIFENACIN ACTIVE MOIETY A8910SQJ1U VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [CARDINAL HEALTH] 2 SOLIFENACIN ACTIVE MOIETY A8910SQJ1U VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51248-151 VESICARE (SOLIFENACIN SUCCINATE) TABLET, FILM COATED [ASTELLAS PHARMA US, INC.] 29 Current NDC, Legacy NDC, 2 package rows 20230511_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51248-151-01 51248015101 30 TABLET, FILM COATED in 1 BOTTLE (51248-151-01) 2005-01-05 2026-08-31 No No Current 51248-151-03 51248015103 90 TABLET, FILM COATED in 1 BOTTLE (51248-151-03) 2005-01-05 0000-00-00 No No Current 51248-151-52 51248015152 100 TABLET, FILM COATED in 1 BLISTER PACK (51248-151-52) 2005-01-05 0000-00-00 No No Current