Divalproex Sodium

Product NDC: 0378-0472
11-digit product format: 003780472
Labeler code: 0378
Product ID: 0378-0472_346235bd-f9cb-4693-9ad2-d62cbe9c62ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA077567
Marketing category: ANDA
Marketing start: 2009-01-29
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: 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077567-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-01-29
A077567-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077567-001	AB
A077567-002	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	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077567-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077567-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-01-29	`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	A077567-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077567-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077567-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077567-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077567-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077567-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077567-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077567-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077567-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077567-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077567-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077567-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077567-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077567-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077567-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077567-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077567-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077567-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077567-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077567-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077567-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077567-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077567-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077567-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077567-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077567-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077567-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077567-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077567-002	AB	1	`bb7c543d1eb4…`

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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099563	Internal RxNorm lookup
1099569	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
00332c65-edad-a153-9c78-628931daa732	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0378-0472-01	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
0378-0472-01	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
0378-0472-01	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
0378-0472-01	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
0378-0472-05	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
0378-0472-05	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
0378-0472-05	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
0378-0472-05	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-0472-01	Divalproex Sodium	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100		39
0378-0472-05	Divalproex Sodium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	500		39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0472-01	EA - Each	0378-0472	b6bbc5ce-91cc-44c2-a371-ef799274a7d2	1	2012-07-24
0378-0472-05	EA - Each	0378-0472	8c34a8f0-b709-419d-8c66-64a1ea2e0f65	1	2012-07-24
0378-0472-77	EA - Each	0378-0472	3c6effff-5a2f-48d8-8551-bfec7730edb1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	14
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0472	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	33	Current NDC, Legacy NDC, 2 package rows	20250228_00332c65-edad-a153-9c78-628931daa732.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	Mylan Pharmaceuticals Inc.	00332c65-edad-a153-9c78-628931daa732	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567 ndc (product): 0378-0472
Divalproex Sodium	DIVALPROEX SODIUM	Safecor Health, LLC	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567
Divalproex Sodium	DIVALPROEX SODIUM	Mylan Institutional Inc.	b367d81d-4eca-4e28-b490-34be4c003561	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	bf34dd25-abe3-4587-b481-df052f085429	2023-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	0f5bb45e-836b-48ce-9764-2d50edcb202c	2023-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077567 application number: ANDA077567

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
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	00332c65-edad-a153-9c78-628931daa732	39
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	00332c65-edad-a153-9c78-628931daa732	39
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	00332c65-edad-a153-9c78-628931daa732	39
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	00332c65-edad-a153-9c78-628931daa732	39
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	00332c65-edad-a153-9c78-628931daa732	39
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	00332c65-edad-a153-9c78-628931daa732	39
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	b367d81d-4eca-4e28-b490-34be4c003561	22
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	b367d81d-4eca-4e28-b490-34be4c003561	22
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	b367d81d-4eca-4e28-b490-34be4c003561	22
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	b367d81d-4eca-4e28-b490-34be4c003561	22
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	b367d81d-4eca-4e28-b490-34be4c003561	22
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	b367d81d-4eca-4e28-b490-34be4c003561	22
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	bf34dd25-abe3-4587-b481-df052f085429	3
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	bf34dd25-abe3-4587-b481-df052f085429	3
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	bf34dd25-abe3-4587-b481-df052f085429	3
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	3aec1944-86a1-490c-a734-d9dd3b52c9d6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0472-01	00378047201	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-01)	2009-01-29	0000-00-00	No	No	Current
0378-0472-05	00378047205	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-05)	2009-01-29	0000-00-00	No	No	Current
0378-0472-77	00378047277	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-77)	2010-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex Sodium	Mylan Pharmaceuticals Inc.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	39
Divalproex Sodium	Safecor Health, LLC	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	2
Divalproex Sodium	Mylan Institutional Inc.	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	22
Divalproex Sodium	Aphena Pharma Solutions - Tennessee, LLC	2023-08-03	HUMAN PRESCRIPTION DRUG LABEL	3
Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	2019-11-25	HUMAN PRESCRIPTION DRUG LABEL	18
Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	2019-10-29	HUMAN PRESCRIPTION DRUG LABEL	2