VESIcare

Product NDC: 51248-151
11-digit product format: 512480151
Labeler code: 51248
Product ID: 51248-151_07e04ccb-62f9-4096-a5c2-0f3f4245ddac
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: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51248-151		D	Discontinued by firm	2026-10-12
excluded package	package	51248-151	51248-151-01	D	Discontinued by firm	2026-10-12
excluded package	package	51248-151	51248-151-03	D	Discontinued by firm	2026-10-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	N021518-001	VESICARE	5MG	TABLET / ORAL		RLD	2004-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021518-002	VESICARE	10MG	TABLET / ORAL		RLD	2004-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021518-001	VESICARE	5MG	TABLET / ORAL		RLD	2004-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021518-002	VESICARE	10MG	TABLET / ORAL		RLD	2004-11-19	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	N021518-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021518-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021518-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021518-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021518-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021518-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021518-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021518-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021518-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021518-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021518-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021518-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021518-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021518-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021518-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021518-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021518-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021518-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021518-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021518-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021518-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021518-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021518-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021518-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021518-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021518-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021518-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021518-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021518-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021518-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021518-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021518-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021518-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021518-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021518-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021518-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021518-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021518-002	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efc179d5-753a-8dcd-90d4-5676a1c31ce3	Product name	7	20250423
7a525cfb-2fd5-4f2e-bf22-13a2c0cea1dd	Product name	1	20201030

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51248-151-01	EA - Each	51248-151	c7b139c0-ad6b-4a9f-93c1-71d5443dcd0b	1	2012-07-24
51248-151-03	EA - Each	51248-151	fb6502be-af28-4152-b1af-f4c25e52a814	1	2012-07-24
51248-151-52	EA - Each	51248-151	ed631c3e-b6d8-493d-9c6f-e4c4cf14f983	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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	Legacy NDC, 2 package rows	20230511_9acee910-cdb2-4052-b8b3-c26aff1c8716.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KKA5DLD701	SOLIFENACIN SUCCINATE	242478-38-2	SOLIFENACIN SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477372	solifenacin succinate 10 MG Oral Tablet	PSN	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
477367	solifenacin succinate 5 MG Oral Tablet	PSN	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
539815	VESICARE 10 MG Oral Tablet	PSN	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
539817	VESICARE 5 MG Oral Tablet	PSN	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
539815	solifenacin succinate 10 MG Oral Tablet [Vesicare]	SBD	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
539817	solifenacin succinate 5 MG Oral Tablet [Vesicare]	SBD	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
477372	solifenacin succinate 10 MG Oral Tablet	SCD	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
477367	solifenacin succinate 5 MG Oral Tablet	SCD	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
539815	VESIcare 10 MG Oral Tablet	SY	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
539817	VESIcare 5 MG Oral Tablet	SY	9acee910-cdb2-4052-b8b3-c26aff1c8716	30
477372	solifenacin succinate 10 MG Oral Tablet	PSN	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
477367	solifenacin succinate 5 MG Oral Tablet	PSN	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
539815	VESICARE 10 MG Oral Tablet	PSN	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
539817	VESICARE 5 MG Oral Tablet	PSN	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
539815	solifenacin succinate 10 MG Oral Tablet [Vesicare]	SBD	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
539817	solifenacin succinate 5 MG Oral Tablet [Vesicare]	SBD	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
477372	solifenacin succinate 10 MG Oral Tablet	SCD	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
477367	solifenacin succinate 5 MG Oral Tablet	SCD	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
539815	VESIcare 10 MG Oral Tablet	SY	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2
539817	VESIcare 5 MG Oral Tablet	SY	e433dc68-6b2a-4c48-beae-4ec946f1ff1e	2

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	0000-00-00	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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VESIcare	Astellas Pharma US, Inc.	2022-10-31	HUMAN PRESCRIPTION DRUG LABEL	30
VESIcare	REMEDYREPACK INC.	2019-11-05	HUMAN PRESCRIPTION DRUG LABEL	4
VESIcare	Cardinal Health	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	12
VESIcare	Cardinal Health	2015-04-29	HUMAN PRESCRIPTION DRUG LABEL	2
VESIcare	Physicians Total Care, Inc.	2012-03-06	HUMAN PRESCRIPTION DRUG LABEL	2