Solifenacin Succinate

Product NDC: 69238-1309
Requested package NDC: 69238-1309-3
11-digit product format: 692381309
Labeler code: 69238
Product ID: 69238-1309_aedb14aa-4f14-4bd7-a3fe-cb5b76a70555
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: solifenacin succinate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA209719
Marketing category: ANDA
Marketing start: 2019-05-20
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69238-1309	69238-1309-3	D	Discontinued by firm		2026-10-05

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
A209719-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL			2019-05-20
A209719-002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL			2019-05-20

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	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209719-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209719-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209719-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209719-002	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A209719-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209719-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209719-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209719-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209719-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209719-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209719-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209719-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209719-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209719-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209719-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209719-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209719-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209719-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209719-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209719-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1309-3	EA - Each	69238-1309	7f082f01-a8d0-40e6-87ae-5fabb606339c	1	2019-06-19
69238-1309-9	EA - Each	69238-1309	ae1d6e08-ec59-46db-8531-f8f24cf37f01	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1309	SOLIFENACIN SUCCINATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	6	Legacy NDC	20231128_5fca0c16-45e0-4bf9-b0a5-09917db24e9d.zip

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
69238-1309-3	69238130903	30 TABLET, FILM COATED in 1 BOTTLE (69238-1309-3)	2019-05-20	0000-00-00	No	No	Current