Divalproex Sodium

Product NDC: 53808-1065
11-digit product format: 538081065
Labeler code: 53808
Product ID: 53808-1065_9a4fc6df-9de5-42e6-9c30-57be15f3c153
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA090554
Marketing category: ANDA
Marketing start: 2014-11-01
Marketing end: 0000-00-00
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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-1065		I	Inactivated by FDA		2026-09-09
excluded package	package	53808-1065	53808-1065-1	I	Inactivated by FDA		2026-09-09

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 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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`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	53808-1065-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-1065-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-1065-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-1065-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-1065-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-1065-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-1065-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-1065-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-1065-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-1065-1	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090554-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21
A090554-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21
A090554-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090554-001	AB
A090554-002	AB
A090554-003	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 4 · 126 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	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090554-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090554-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090554-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A090554-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090554-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090554-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090554-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090554-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090554-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090554-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090554-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090554-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090554-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090554-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090554-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090554-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090554-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090554-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090554-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090554-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090554-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090554-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090554-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090554-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090554-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090554-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090554-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090554-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090554-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090554-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090554-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090554-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090554-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090554-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090554-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090554-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090554-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090554-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090554-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090554-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090554-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090554-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090554-001	AB	1	`1e350fbaab3a…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
57fc3d01-4737-4091-9728-9e8a4c9e708d	Product name	1	20200121
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645	Product name	1	20140508
97fce1a8-50c4-f088-0e31-64d82b6e9081	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1065-1	2020-01-31	C162847	48780-1	9d75b9d0-01ff-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use divalproex sodium delayed-release tablets, USP safely and effectively. See full prescribing information for divalproex sodium delayed-release tablets, USP. DIVALPROEX sodium delayed-release tablets, USP for oral use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1065-1	Divalproex Sodium	30 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METHYLENE CHLORIDE	INACTIVE INGREDIENT	588X2YUY0A	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
VANILLIN	INACTIVE INGREDIENT	CHI530446X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1065	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20150107_c0469f5a-68ab-4dbc-a9c7-9a1043e350a5.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	0339e27d-3dbf-4c37-a14e-f53557c08e19	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	5926c3ff-c995-4789-941c-d38aa7db94dc	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	St. Mary's Medical Park Pharmacy	35a91dd3-19d0-09cb-e063-6394a90af01b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	a999f402-be1d-4153-b743-cfdb95ed1562	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	Rising Pharma Holdings, Inc.	6316061c-9758-4f38-9cb2-7ca833dd20bf	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	Aurobindo Pharma Limited	dbd47222-14f1-4588-a009-9b81b55ca60d	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	fbaff0ae-431e-4e83-81c2-41eb4b18ee87	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	64b509bc-f398-48ad-bdcb-9904e61d9225	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	63d61062-2700-47f4-8ab4-3bd641b81fe1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090554 application number: ANDA090554

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
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	PSN	c0469f5a-68ab-4dbc-a9c7-9a1043e350a5	1
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	SCD	c0469f5a-68ab-4dbc-a9c7-9a1043e350a5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-1065-1	53808106501	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex Sodium	State of Florida DOH Central Pharmacy	2015-01-03	HUMAN PRESCRIPTION DRUG LABEL	1