Divalproex sodium

Product NDC: 50090-5783
Requested package NDC: 50090-5783-1
11-digit product format: 500905783
Labeler code: 50090
Product ID: 50090-5783_2d888afa-bc4d-463e-8d3f-88743a09965f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA209286
Marketing category: ANDA
Marketing start: 2020-09-18
Marketing end: 0000-00-00
Substance: DIVALPROEX SODIUM
Active strength: 500 1/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-5783	50090-5783-1	D	Discontinued by firm		2026-08-17

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209286-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2019-10-18
A209286-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2019-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209286-001	AB
A209286-002	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 2 · 80 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
2026-08-18 06:07:40	2026-07	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209286-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209286-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209286-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209286-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209286-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5783-0	2024-06-14	These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
50090-5783-1	2024-06-14	These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
50090-5783-0	2023-01-30	These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
50090-5783-1	2023-01-30	These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5783-0	EA - Each	50090-5783	0ebf7002-d5bf-4595-8169-ba37f0474e59	1	2024-07-12
50090-5783-1	EA - Each	50090-5783	41c7f523-8287-4a12-8565-0b0cc4afe4b2	1	2024-07-12

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	aa386ae3-ceac-4e3b-8fb1-ced3107a4c54	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	PD-Rx Pharmaceuticals, Inc.	392df14f-4d65-4be9-973b-1f0ce1013d8f	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	6af40b06-0a92-454c-9277-80e89de27231	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	Lupin Pharmaceuticals, Inc.	1f081c74-9f73-4ed9-9157-8d73d586a409	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals, Inc.	83a77f60-ed58-4fa0-a584-e6a0c767d19d	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0822300b-68c0-4e70-b1ba-8eb42cf373f7	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex Sodium ER	DIVALPROEX SODIUM ER	Direct_Rx	f86f185b-4acb-43b5-e053-6394a90a681c	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286
Divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	319bbead-bec8-4bb7-9ecb-b2e161c44b8d	2024-09-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209286 application number: ANDA209286

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
644VL95AO6	DIVALPROEX SODIUM	76584-70-8	DIVALPROEX SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5783-1	50090578301	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5783-1)	2021-10-08	0000-00-00	No	No	Current