Solifenacin Succinate

Product NDC: 71205-583
11-digit product format: 712050583
Labeler code: 71205
Product ID: 71205-583_585474af-65d8-4ed1-9793-8439d80212fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Solifenacin Succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA209333
Marketing category: ANDA
Marketing start: 2019-05-20
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: 2027-12-31
Current FDA listing: Yes

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
A209333-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20
A209333-002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209333-001	AB
A209333-002	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209333-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209333-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209333-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209333-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209333-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209333-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209333-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209333-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209333-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209333-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209333-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209333-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209333-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209333-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209333-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209333-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209333-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209333-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209333-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209333-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209333-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209333-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209333-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209333-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209333-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209333-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209333-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209333-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209333-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209333-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209333-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209333-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209333-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209333-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209333-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209333-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209333-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209333-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209333-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209333-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Solifenacin Succinate
Listing expiration: 2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
70fece2c-a59f-43f9-abbf-ac67500e90bb	Available on FDA.report

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Apotex Corp.	1d96b386-febf-a510-a896-033e832c8f30	2025-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209333 application number: ANDA209333
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	70fece2c-a59f-43f9-abbf-ac67500e90bb	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209333 application number: ANDA209333 ndc (product): 71205-583
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	d6525817-bea1-4a4c-bed4-4873ee202cc8	2021-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209333 application number: ANDA209333

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-583-30	71205058330	30 TABLET, FILM COATED in 1 BOTTLE (71205-583-30)	2021-06-25	0000-00-00	No	No	Current
71205-583-60	71205058360	60 TABLET, FILM COATED in 1 BOTTLE (71205-583-60)	2021-06-25	0000-00-00	No	No	Current
71205-583-90	71205058390	90 TABLET, FILM COATED in 1 BOTTLE (71205-583-90)	2021-06-25	0000-00-00	No	No	Current