Divalproex sodium

Product NDC: 65862-594
11-digit product format: 658620594
Labeler code: 65862
Product ID: 65862-594_73af0685-290a-4d1d-9c6e-741b664cca3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA202419
Marketing category: ANDA
Marketing start: 2014-06-02
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	65862-594		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	65862-594	65862-594-22	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-594-22	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-594-22	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-594-22	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-594-22	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-594-22	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-594-22	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-594-22	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-594-22	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-594-22	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-594-22	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-594-22	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-594-22	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-594-22	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-594-22	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-594-22	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-594-22	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-594-22	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-594-22	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-594-22	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-594-22	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-594-22	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A202419-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2014-06-02
A202419-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2014-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202419-001	AB
A202419-002	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	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`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	A202419-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202419-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202419-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202419-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202419-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202419-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202419-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202419-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202419-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202419-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202419-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202419-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202419-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202419-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202419-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202419-002	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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6240cee7-6aa8-425c-ba46-f889a640f0fa	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
65862-594-01	Divalproex sodium	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	29
65862-594-05	Divalproex sodium	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	29
65862-594-10	Divalproex sodium	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	29
65862-594-10	Divalproex sodium	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	29
65862-594-60	Divalproex sodium	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	29
65862-594-99	Divalproex sodium	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-594-01	EA - Each	65862-594	a2e2b46f-3bfe-4a40-9e12-2e1bc47d695e	1	2014-07-02
65862-594-99	EA - Each	65862-594	337bdc0c-238f-4d44-bfc5-790aa8934795	1	2014-07-02

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 [AUROBINDO PHARMA LIMITED]	7
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-594	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	27	Current NDC, Legacy NDC, 6 package rows	20250308_6240cee7-6aa8-425c-ba46-f889a640f0fa.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	Aurobindo Pharma Limited	6240cee7-6aa8-425c-ba46-f889a640f0fa	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419 ndc (product): 65862-594
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	aab6b411-11e9-4a16-afb6-d471ba4756e9	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	41e32cd5-1393-4ef1-81cb-8e3795e30682	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	7e96b724-5f5f-43cb-8d8b-adff3e1fc779	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	3df910c5-b6f0-4a65-9640-b702ecea49f9	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	94eac383-a89f-4128-b81c-076640b8edcf	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0669ac77-10df-48af-bc42-55e768b69e4f	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	e4a815eb-ea20-482a-bb67-06ab34264515	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	9a9f5f24-e421-406f-ac91-d1f964245f54	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	177e34e9-f74d-42aa-8e3c-5fb4f41c2322	2018-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	ad5e8bd8-c923-40f0-a106-55620c4247d7	2018-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419

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	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	100
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	100
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	100
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	6240cee7-6aa8-425c-ba46-f889a640f0fa	29
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	6240cee7-6aa8-425c-ba46-f889a640f0fa	29
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	6240cee7-6aa8-425c-ba46-f889a640f0fa	29
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	6240cee7-6aa8-425c-ba46-f889a640f0fa	29
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	6240cee7-6aa8-425c-ba46-f889a640f0fa	29
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	6240cee7-6aa8-425c-ba46-f889a640f0fa	29
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	7e96b724-5f5f-43cb-8d8b-adff3e1fc779	18
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	7e96b724-5f5f-43cb-8d8b-adff3e1fc779	18
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	7e96b724-5f5f-43cb-8d8b-adff3e1fc779	18
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	ad5e8bd8-c923-40f0-a106-55620c4247d7	1
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	ad5e8bd8-c923-40f0-a106-55620c4247d7	1
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	ad5e8bd8-c923-40f0-a106-55620c4247d7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-594-01	65862059401	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-01)		2014-06-02	0000-00-00	No	No	Current
65862-594-05	65862059405	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-05)		2014-06-02	0000-00-00	No	No	Current
65862-594-10	65862059410	10 BLISTER PACK in 1 CARTON (65862-594-10) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2014-06-02	0000-00-00	No	No	Current
65862-594-22	65862059422	2000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-594-22)		02-JUN-14				Current
65862-594-60	65862059460	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-60)		2014-06-02	0000-00-00	No	No	Current
65862-594-99	65862059499	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-99)		2014-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex sodium	Aurobindo Pharma Limited	2026-07-21	Human Prescription Drug Label	30
Divalproex sodium	REMEDYREPACK INC.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	18
Divalproex sodium	Bryant Ranch Prepack	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	100
Divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	2018-10-16	Human Prescription Drug Label	1