VESIcare

Product NDC: 70518-2094
11-digit product format: 705182094
Labeler code: 70518
Product ID: 70518-2094_89809956-6c40-1dd3-e053-2a95a90a6d6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: solifenacin succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA021518
Marketing category: NDA
Marketing start: 2019-05-21
Marketing end: 0000-00-00
Substance: SOLIFENACIN SUCCINATE
Active strength: 5 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-2094		D	Discontinued by firm		2026-08-03
excluded package	package	70518-2094	70518-2094-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2094-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2094-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2094-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2094-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2094-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2094-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2094-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2094-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2094-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2094-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2094-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2094-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021518-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021518-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021518-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021518-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021518-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021518-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021518-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021518-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021518-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021518-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021518-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021518-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021518-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021518-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021518-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021518-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021518-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021518-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021518-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021518-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021518-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021518-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021518-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021518-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021518-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021518-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021518-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021518-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021518-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021518-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021518-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021518-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021518-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021518-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021518-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021518-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021518-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021518-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021518-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021518-002	AB	1	`87673890dc5c…`

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…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VESIcare	SOLIFENACIN SUCCINATE	Astellas Pharma US, Inc.	9acee910-cdb2-4052-b8b3-c26aff1c8716	2022-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021518 application number: NDA021518