Solifenacin Succinate

Product NDC: 71205-987
11-digit product format: 712050987
Labeler code: 71205
Product ID: 71205-987_b4c66056-a377-4e1a-8708-283ab85b2fb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Solifenacin Succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA211657
Marketing category: ANDA
Marketing start: 2019-09-25
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: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71205-987		D	Discontinued by firm	2026-08-07
excluded package	package	71205-987	71205-987-30	D	Discontinued by firm	2026-08-07
excluded package	package	71205-987	71205-987-60	D	Discontinued by firm	2026-08-07
excluded package	package	71205-987	71205-987-90	D	Discontinued by firm	2026-08-07

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 · 8 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	71205-987-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-987-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-987-60	`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	71205-987-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-987-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-987-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A211657-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20
A211657-002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	RS	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
A211657-001	AB
A211657-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	RS	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211657-002	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	A211657-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211657-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211657-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211657-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211657-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211657-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211657-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211657-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211657-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211657-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211657-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211657-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211657-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211657-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211657-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211657-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211657-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211657-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-987-30	EA - Each	71205-987	0734b357-cab3-4a7f-aac0-3eb4aa7b616c	1	2021-06-02
71205-987-60	EA - Each	71205-987	e2975ab0-70ee-4f69-8fe6-783ef6fc3712	1	2021-06-02
71205-987-90	EA - Each	71205-987	1efaa2d2-90f9-40d1-82e7-7ad8f3de991b	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-987	SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP]	2	Legacy NDC	20200710_6e140c11-2b1a-4c3b-9df7-b1b3aa33cfa2.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	c84682ca-afca-a066-e053-2995a90a3257	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	7eb1a5d6-4972-44f4-8ab9-80b932bf81e0	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	49346a96-3d96-4702-b96e-94e635510dba	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	a6f154d9-7463-4b80-b80e-c06a06e36141	2021-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657

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
71205-987-30	71205098730	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-987-30)	2020-05-01	0000-00-00	No	No	Current
71205-987-60	71205098760	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-987-60)	2020-05-01	0000-00-00	No	No	Current
71205-987-90	71205098790	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-987-90)	2020-05-01	0000-00-00	No	No	Current