Solifenacin Succinate

Product NDC: 67184-0517
11-digit product format: 671840517
Labeler code: 67184
Product ID: 67184-0517_4ad0176d-0102-457a-9fcb-472dcedd9709
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Solifenacin Succinate Tablets
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Qilu Pharmaceutical Co., Ltd.
Application: ANDA209333
Marketing category: ANDA
Marketing start: 2020-04-01
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: 2026-12-31
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
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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209333-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209333-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A209333-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209333-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209333-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209333-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Solifenacin Succinate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOLIFENACIN SUCCINATE	10 mg/1

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
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
67184-0517-1	67184051701	30 TABLET, FILM COATED in 1 BOTTLE (67184-0517-1)	2020-04-01	0000-00-00	No	No	Current
67184-0517-2	67184051702	90 TABLET, FILM COATED in 1 BOTTLE (67184-0517-2)	2020-04-01	0000-00-00	No	No	Current
67184-0517-3	67184051703	2000 TABLET, FILM COATED in 1 BOTTLE (67184-0517-3)	2020-04-01	0000-00-00	No	No	Current
67184-0517-4	67184051704	40 TABLET, FILM COATED in 1 BLISTER PACK (67184-0517-4)	2020-04-01	0000-00-00	No	No	Current