Solifenacin Succinate

Product NDC: 71205-561
11-digit product format: 712050561
Labeler code: 71205
Product ID: 71205-561_a3a77fb3-af3f-4c6f-be7e-8ce349d2a2cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Solifenacin Succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA210224
Marketing category: ANDA
Marketing start: 2019-05-21
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A210224-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20
A210224-002	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
A210224-001	AB
A210224-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210224-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210224-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210224-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210224-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210224-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210224-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210224-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210224-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210224-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210224-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210224-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210224-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210224-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210224-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210224-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210224-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210224-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210224-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210224-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210224-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210224-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210224-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210224-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210224-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210224-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210224-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210224-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210224-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210224-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210224-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210224-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210224-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210224-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210224-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210224-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210224-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210224-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210224-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210224-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210224-002	AB	1	`3a93d1ddd44b…`

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	5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
477367	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c67107f4-348b-4a23-a67c-26fd8241ebd6	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-561-30	Solifenacin Succinate	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
71205-561-60	Solifenacin Succinate	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
71205-561-90	Solifenacin Succinate	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-561-30	EA - Each	71205-561	d6fd25c2-044f-4204-9e56-89fd77719e75	1	2021-06-02
71205-561-90	EA - Each	71205-561	a2abe12a-1fd7-4c6e-abb8-7155089189bf	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-561	SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 3 package rows	20220604_c67107f4-348b-4a23-a67c-26fd8241ebd6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	f0b8f111-1d76-4b04-9e2f-9fca9e5a0b00	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	e04812c2-2ff7-4dff-9122-518c18f4935e	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	3788df43-42dd-4778-8289-e32b5844358e	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	dadb9462-953e-4319-b9f8-5b7255d1cf9c	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	8d65dcb9-aa67-4cfb-9d15-43d0de327bd7	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2462e9a4-66a7-4340-9a81-617f3417b495	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	663d992d-23cc-4a8e-acd5-a4bea505ba3a	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2dfc5d69-8f35-4f57-90b7-46a5f0f0febe	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Ascend Laboratories, LLC	97d8a21e-4618-460f-8cf5-97a9d946039e	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	c67107f4-348b-4a23-a67c-26fd8241ebd6	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 71205-561

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
477367	solifenacin succinate 5 MG Oral Tablet	PSN	c67107f4-348b-4a23-a67c-26fd8241ebd6	2
477367	solifenacin succinate 5 MG Oral Tablet	SCD	c67107f4-348b-4a23-a67c-26fd8241ebd6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-561-30	71205056130	30 TABLET, FILM COATED in 1 BOTTLE (71205-561-30)	2021-05-07	0000-00-00	No	No	Current
71205-561-60	71205056160	60 TABLET, FILM COATED in 1 BOTTLE (71205-561-60)	2021-05-07	0000-00-00	No	No	Current
71205-561-90	71205056190	90 TABLET, FILM COATED in 1 BOTTLE (71205-561-90)	2021-05-07	0000-00-00	No	No	Current