divalproex sodium

Product NDC: 50090-7763
11-digit product format: 500907763
Labeler code: 50090
Product ID: 50090-7763_ff1828be-6b93-4a6c-a181-108d018c83ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078853
Marketing category: ANDA
Marketing start: 2024-06-26
Substance: DIVALPROEX SODIUM
Active strength: 250 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 1.

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
A078853-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25
A078853-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25
A078853-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078853-001	AB
A078853-002	AB
A078853-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078853-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078853-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078853-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-11-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078853-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078853-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078853-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078853-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078853-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078853-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078853-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078853-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078853-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078853-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078853-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078853-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078853-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078853-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078853-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078853-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078853-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078853-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078853-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078853-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078853-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078853-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078853-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078853-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078853-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078853-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078853-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078853-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078853-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078853-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078853-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078853-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078853-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078853-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078853-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078853-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078853-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078853-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078853-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078853-001	AB	1	`8072bd15b7f6…`

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	250 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
1099678	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
ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91	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
50090-7763-0	divalproex sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30		1
50090-7763-1	divalproex sodium	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7763-0	EA - Each	50090-7763	e9ebba97-b492-4d4f-ad6b-db819e6e7331	1	2025-12-16
50090-7763-1	EA - Each	50090-7763	9c708d99-9618-409e-938a-9da28cdc9674	1	2025-12-16

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	55f1614b-aadc-34ca-e063-6394a90ae2a7	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	Bionpharma Inc.	19064624-81d1-4ce3-bfe4-955bad6af6a2	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	c971b50d-0f78-422f-abee-1c5b4e1d20e7	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	Preferred Pharmaceuticals Inc.	dbd1d178-77a3-46ff-985d-307dffaed1ad	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	4834732f-6044-946c-e063-6394a90a5da3	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	f936b9d0-a58f-4fa5-8db9-752dabb837a6	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853 ndc (product): 50090-7763
divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	df8f3825-a037-4343-859d-e59bca5f1e43	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853
divalproex sodium	DIVALPROEX SODIUM	Proficient Rx LP	15ffe3d8-d483-4c45-adc4-1cc8a5b68d19	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078853 application number: ANDA078853

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	ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91	1
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	SCD	ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7763-0	50090776300	30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7763-0)	2025-11-11	No	No	Current
50090-7763-1	50090776301	100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7763-1)	2025-11-11	No	No	Current