divalproex sodium

Product NDC: 70518-4557
Requested package NDC: 70518-4557-0
11-digit product format: 705184557
Labeler code: 70518
Product ID: 70518-4557_49646ced-d52b-dab7-e063-6294a90aba3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA214643
Marketing category: ANDA
Marketing start: 2026-01-27
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 1.

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
A214643-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2022-02-25
A214643-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2022-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214643-001	AB
A214643-002	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 2 · 62 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	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214643-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214643-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2022-02-25	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 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	A214643-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214643-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214643-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214643-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214643-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214643-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214643-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214643-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214643-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214643-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214643-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214643-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214643-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214643-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214643-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214643-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214643-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214643-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214643-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214643-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214643-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214643-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214643-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214643-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214643-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214643-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214643-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214643-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214643-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214643-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214643-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214643-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214643-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214643-002	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214643-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214643-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214643-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214643-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214643-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214643-002	AB	1	`ea1830bbd6c7…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099563	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
93d6ddb5-7143-4917-baf7-31cbf8a90e8d	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
70518-4557-0	divalproex sodium	30 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	30		1

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
divalproex sodium	DIVALPROEX SODIUM	Unichem Pharmaceuticals (USA), Inc.	1d4129ae-0ce8-4a04-9f9d-c770508de8ed	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643
divalproex sodium	DIVALPROEX SODIUM	BluePoint Laboratories	352b4c3c-e419-4827-9e00-febb0164e0f5	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643
divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	93d6ddb5-7143-4917-baf7-31cbf8a90e8d	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643 ndc (package): 70518-4557-0 ndc (product): 70518-4557 ndc11 (package): 70518455700
divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	d48af379-bd5d-48e1-ad2d-86c493d9cbea	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643
divalproex sodium	DIVALPROEX SODIUM	American Health Packaging	b12b76a0-4b6e-4cd4-9508-10a2c84d8beb	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643
divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	e5fcf5b1-263e-43e0-9424-e613d5cca3fa	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	46b2e8a9-5d50-d0b2-e063-6294a90a1b47	2025-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643
divalproex sodium	DIVALPROEX SODIUM	Coupler LLC	3eee54a6-5b4c-330d-e063-6394a90a9f18	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214643 application number: ANDA214643

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	93d6ddb5-7143-4917-baf7-31cbf8a90e8d	1
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	93d6ddb5-7143-4917-baf7-31cbf8a90e8d	1
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	93d6ddb5-7143-4917-baf7-31cbf8a90e8d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4557-0	70518455700	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4557-0)	2026-01-27	No	No	Current