Divalproex sodium

Product NDC: 0904-6615
11-digit product format: 009046615
Labeler code: 0904
Product ID: 0904-6615_d19fd110-9f66-41ec-a016-f02ec3b37b73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA078979
Marketing category: ANDA
Marketing start: 2009-01-23
Substance: DIVALPROEX SODIUM
Active strength: 125 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: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078979-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078979-001	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 · 42 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	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078979-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A078979-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078979-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078979-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078979-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078979-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078979-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078979-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078979-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078979-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078979-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078979-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078979-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078979-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078979-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078979-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078979-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078979-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078979-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078979-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078979-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078979-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078979-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078979-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078979-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078979-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078979-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078979-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078979-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078979-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078979-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Divalproex sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIVALPROEX SODIUM	125 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099596	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
4a0fa934-ec8c-460e-86eb-11281728fe85	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
57fc3d01-4737-4091-9728-9e8a4c9e708d	Product name	1	20200121
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	Strength	SPL version
0904-6615-61	Divalproex sodium	100 in 1 CARTON	CAPSULE, DELAYED RELEASE	100		12
0904-6615-61	Divalproex sodium	1 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6615-61	EA - Each	0904-6615	17dabc2d-5924-4905-94e8-2965e0401e80	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6615	DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20250418_4a0fa934-ec8c-460e-86eb-11281728fe85.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	4a0fa934-ec8c-460e-86eb-11281728fe85	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979 ndc (product): 0904-6615
Divalproex sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	0816a066-9ee3-4c23-944d-3539fc2c12bf	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979
Divalproex sodium	DIVALPROEX SODIUM	Dr. Reddy's Laboratories Ltd	f911748c-fb3a-fe1a-ab2a-4b40455e05ef	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	589ae3a6-8b2e-d931-d36b-1937287ab5c0	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979
Divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	388fd4bc-f12f-4e55-a1e7-72aa585519fa	2024-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078979 application number: ANDA078979

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
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	PSN	4a0fa934-ec8c-460e-86eb-11281728fe85	12
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	SCD	4a0fa934-ec8c-460e-86eb-11281728fe85	12
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	PSN	0816a066-9ee3-4c23-944d-3539fc2c12bf	7
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	SCD	0816a066-9ee3-4c23-944d-3539fc2c12bf	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6615-61	00904661561	100 BLISTER PACK in 1 CARTON (0904-6615-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	100 blister pack	2009-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex sodium	Major Pharmaceuticals	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	13
Divalproex sodium	Cardinal Health 107, LLC	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	7