Divalproex sodium

Product NDC: 68788-7177
11-digit product format: 687887177
Labeler code: 68788
Product ID: 68788-7177_c4cc1bf8-dfad-4ccd-8d97-2c3d00871430
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202419
Marketing category: ANDA
Marketing start: 2018-07-17
Marketing end: 0000-00-00
Substance: DIVALPROEX SODIUM
Active strength: 500 mg/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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7177		D	Discontinued by firm	2026-08-17
excluded package	package	68788-7177	68788-7177-3	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7177	68788-7177-6	D	Discontinued by firm	2026-08-17
excluded package	package	68788-7177	68788-7177-9	D	Discontinued by firm	2026-08-17

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
A202419-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2014-06-02
A202419-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2014-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202419-001	AB
A202419-002	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 · 84 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	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A202419-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202419-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202419-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202419-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202419-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202419-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202419-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202419-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202419-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202419-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202419-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202419-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202419-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202419-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202419-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202419-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7177-3	EA - Each	68788-7177	0b6c1dc6-c07b-47a7-8d00-4a2960ef2024	1	2018-09-05
68788-7177-6	EA - Each	68788-7177	99304f4b-1cb8-4ceb-9fe3-5a6ff011b115	1	2018-09-05
68788-7177-9	EA - Each	68788-7177	4af0b29d-5ad8-420b-9eed-d6cbdcae5a6c	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7177	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]	8	Legacy NDC	20240606_4817535e-d9e9-4cc0-9212-e232cbd8c2fd.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	Aurobindo Pharma Limited	6240cee7-6aa8-425c-ba46-f889a640f0fa	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	aab6b411-11e9-4a16-afb6-d471ba4756e9	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	41e32cd5-1393-4ef1-81cb-8e3795e30682	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	7e96b724-5f5f-43cb-8d8b-adff3e1fc779	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	3df910c5-b6f0-4a65-9640-b702ecea49f9	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	94eac383-a89f-4128-b81c-076640b8edcf	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0669ac77-10df-48af-bc42-55e768b69e4f	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	e4a815eb-ea20-482a-bb67-06ab34264515	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	9a9f5f24-e421-406f-ac91-d1f964245f54	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	177e34e9-f74d-42aa-8e3c-5fb4f41c2322	2018-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	ad5e8bd8-c923-40f0-a106-55620c4247d7	2018-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419

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
68788-7177-3	68788717703	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7177-3)	2018-07-17	0000-00-00	No	No	Current
68788-7177-6	68788717706	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7177-6)	2018-07-17	0000-00-00	No	No	Current
68788-7177-9	68788717709	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7177-9)	2018-07-17	0000-00-00	No	No	Current