Divalproex Sodium

Product NDC: 43353-547
11-digit product format: 433530547
Labeler code: 43353
Product ID: 43353-547_aea9bd15-0319-4fa0-ab51-9d4df59ec7b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077567
Marketing category: ANDA
Marketing start: 2009-02-02
Marketing end: 0000-00-00
Substance: DIVALPROEX SODIUM
Active strength: 500 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: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-547		I	Inactivated by FDA	2026-08-17
excluded package	package	43353-547	43353-547-53	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-547	43353-547-60	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-547	43353-547-70	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-547	43353-547-80	I	Inactivated by FDA	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 2 · 75 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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-547-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-547-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-547-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-547-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-547-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-547-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-547-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-547-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-547-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-547-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-547-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-547-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-547-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-547-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-547-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-547-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-547-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-547-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-547-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-547-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-547-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-547-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-547-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-547-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-547-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-547-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-547-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-547-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-547-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-547-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-547-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-547-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-547-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-547-70	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-547-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-547-53	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-547-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-547-70	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-547-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-547-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-547-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-547-70	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-547-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-547-53	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-547-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-547-70	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-547-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-547-53	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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
43353-547-53	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, USP for oral use Initial U.S. Approval: 2000
43353-547-60	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, USP for oral use Initial U.S. Approval: 2000
43353-547-70	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, USP for oral use Initial U.S. Approval: 2000
43353-547-80	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, USP for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-547-53	Divalproex Sodium	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	3
43353-547-60	Divalproex Sodium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	3
43353-547-70	Divalproex Sodium	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	120	3
43353-547-80	Divalproex Sodium	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	180	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-547-53	EA - Each	43353-547	077e3bfd-d188-4b5e-9633-aa896c8ca9c0	1	2014-06-03
43353-547-60	EA - Each	43353-547	71554c0e-ab9a-4cff-a4ec-1f5235d68660	1	2014-06-03
43353-547-70	EA - Each	43353-547	deccde2f-2fd9-4f02-8df4-ba515cf7e142	1	2014-06-03
43353-547-80	EA - Each	43353-547	92436e33-c536-4295-b861-32ed5c55d1a1	1	2014-06-03

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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-547	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 4 package rows	20191220_badc4aa2-c0fa-4220-9a6c-bc05eeaa1c03.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
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
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	badc4aa2-c0fa-4220-9a6c-bc05eeaa1c03	3
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	badc4aa2-c0fa-4220-9a6c-bc05eeaa1c03	3
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	badc4aa2-c0fa-4220-9a6c-bc05eeaa1c03	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-547-53	43353054753	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-547-53)	2019-02-26	0000-00-00	No	No	Current
43353-547-60	43353054760	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-547-60)	2009-10-15	0000-00-00	No	No	Current
43353-547-70	43353054770	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-547-70)	2010-02-27	0000-00-00	No	No	Current
43353-547-80	43353054780	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-547-80)	2011-06-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex Sodium	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	3