Divalproex Sodium

Product NDC: 0904-6861
11-digit product format: 009046861
Labeler code: 0904
Product ID: 0904-6861_946b4453-7cb3-4bb5-b9ca-cdf732af2ca0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA078597
Marketing category: ANDA
Marketing start: 2008-07-29
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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078597-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29
A078597-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29
A078597-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078597-001	AB
A078597-002	AB
A078597-003	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 4 · 126 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	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078597-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078597-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078597-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078597-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078597-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078597-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078597-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078597-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078597-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078597-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078597-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078597-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078597-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078597-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078597-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078597-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078597-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078597-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078597-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078597-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078597-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078597-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078597-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078597-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078597-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078597-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078597-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078597-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078597-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078597-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078597-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078597-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078597-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078597-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078597-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078597-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078597-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078597-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078597-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078597-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078597-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078597-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078597-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Divalproex Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIVALPROEX SODIUM	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
644VL95AO6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099678	Internal RxNorm lookup
1099870	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b10a892b-b985-4cbc-9547-9ac4b72b784f	Product name	2	20250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69	Product name	7	20250624
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
57fc3d01-4737-4091-9728-9e8a4c9e708d	Product name	1	20200121
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645	Product name	1	20140508
97fce1a8-50c4-f088-0e31-64d82b6e9081	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-6861-61	Divalproex Sodium	100 in 1 CARTON	TABLET, DELAYED RELEASE	100	8
0904-6861-61	Divalproex Sodium	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1	8
0904-6861-90	Divalproex Sodium	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1	8
0904-6861-90	Divalproex Sodium	90 in 1 CARTON	TABLET, DELAYED RELEASE	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6861-61	EA - Each	0904-6861	20bbb3fd-c7ed-4693-894b-0c5c665a867d	1	2021-10-08
0904-6861-90	EA - Each	0904-6861	079a1005-6575-4b7e-9bb2-1d43d4bb3b4c	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6861	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 4 package rows	20250418_fb39a94e-93e6-4afe-a300-f80e8f1e0fa6.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	bb94bbb1-07c1-49be-8c2c-f5635c65366d	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	PD-Rx Pharmaceuticals, Inc.	90225548-85a8-4ea7-95d3-e8231c36fe5a	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	PD-Rx Pharmaceuticals, Inc.	a67855ff-a879-43f0-bca3-94c304348bf5	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	St. Mary's Medical Park Pharmacy	35a95333-9fc1-7a9f-e063-6294a90a9f30	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	79132bea-04d8-4dd9-bd31-07f0ba805c21	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	cf15569c-5010-4e9b-aef0-7df4de5ed04e	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	ed24bb3a-bba1-4b27-8733-96619793fc15	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Sun Pharmaceutical Industries, Inc.	64797788-fdcb-4d12-a1a4-743ad71bd17b	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals Inc.	d1d4d790-73d5-4a3b-a786-99f2c9812546	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	5e59609f-d79d-414b-a6fc-7efb1ba5b200	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597 ndc (product): 0904-6861
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	47412563-ec3e-44fd-9f3f-c00b9b09033a	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	cd6fe37a-d26d-4ae8-a894-b44878e6bf8e	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium D/R	DIVALPROEX SODIUM D/R	Direct_Rx	3aff8f08-d8e8-cd13-e063-6394a90aa00c	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Coupler LLC	38f4f2fd-400b-ccc4-e063-6294a90a5f41	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	ATLANTIC BIOLOGICALS CORP.	57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	48a6e47a-3697-492d-9086-56e4ca0151e5	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	NuCare Pharmaceuticals,Inc.	0bef10ed-e4b5-95ae-e063-6294a90a86eb	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	c8f72850-92d5-4f64-b9f1-657f72bfa15a	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078597 application number: ANDA078597

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	PSN	fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	8
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	PSN	fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	8
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	SCD	fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	8
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	SCD	fb39a94e-93e6-4afe-a300-f80e8f1e0fa6	8
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	PSN	5e59609f-d79d-414b-a6fc-7efb1ba5b200	7
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	PSN	5e59609f-d79d-414b-a6fc-7efb1ba5b200	7
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	SCD	5e59609f-d79d-414b-a6fc-7efb1ba5b200	7
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	SCD	5e59609f-d79d-414b-a6fc-7efb1ba5b200	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6861-61	00904686161	100 BLISTER PACK in 1 CARTON (0904-6861-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK	100 blister pack	2008-07-29	0000-00-00	No	No	Current
0904-6861-90	00904686190	90 BLISTER PACK in 1 CARTON (0904-6861-90) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK	90 blister pack	2008-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex Sodium	Cardinal Health 107, LLC	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	7
Divalproex Sodium	Major Pharmaceuticals	2025-11-21	HUMAN PRESCRIPTION DRUG LABEL	8