Divalproex sodium

Product NDC: 70518-3457
11-digit product format: 705183457
Labeler code: 70518
Product ID: 70518-3457_4b7f1cd7-fe8e-b4b6-e063-6394a90a7914
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213181
Marketing category: ANDA
Marketing start: 2020-07-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3457	70518-3457-0	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213181-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213181-001	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.

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	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213181-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-03-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213181-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213181-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213181-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213181-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213181-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213181-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213181-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213181-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213181-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213181-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213181-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213181-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213181-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213181-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213181-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213181-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213181-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213181-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213181-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213181-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213181-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213181-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213181-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213181-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213181-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213181-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213181-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213181-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213181-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213181-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213181-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213181-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213181-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213181-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213181-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213181-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213181-001	AB	1	`a50c72e98297…`

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
7ead614c-a68d-4a2f-94d0-e6404a8f8760	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	SPL version
70518-3457-0	Divalproex sodium	100 in 1 BOX	CAPSULE, COATED PELLETS	100	10
70518-3457-1	Divalproex sodium	1 in 1 POUCH	CAPSULE, COATED PELLETS	1	10
70518-3457-2	Divalproex sodium	100 in 1 BOX	CAPSULE, COATED PELLETS	100	10
70518-3457-3	Divalproex sodium	1 in 1 POUCH	CAPSULE, COATED PELLETS	1	10
70518-3457-4	Divalproex sodium	30 in 1 BLISTER PACK	CAPSULE, COATED PELLETS	30	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3457	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [REMEDYREPACK INC.]	8	Current NDC, Legacy NDC, 5 package rows	20250417_7ead614c-a68d-4a2f-94d0-e6404a8f8760.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	7ead614c-a68d-4a2f-94d0-e6404a8f8760	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213181 application number: ANDA213181 ndc (product): 70518-3457
Divalproex sodium	DIVALPROEX SODIUM	Ajanta Pharma USA Inc.	773a289b-65ed-4045-80c5-f00e28c1c079	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213181 application number: ANDA213181

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3457-0	70518345700	100 POUCH in 1 BOX (70518-3457-0) > 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-3457-1)	100 pouch	2022-07-20	0000-00-00	No	No	Current
70518-3457-1	70518345701	1 in 1 POUCH						Historical
70518-3457-2	70518345702	100 POUCH in 1 BOX (70518-3457-2) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-3457-3)	100 pouch	2023-08-01		No	No	Current
70518-3457-3	70518345703	1 in 1 POUCH						Historical
70518-3457-4	70518345704	30 CAPSULE, COATED PELLETS in 1 BLISTER PACK (70518-3457-4)		2026-02-18		No	No	Current