Divalproex Sodium Extended-Release

Product NDC: 53808-1061
11-digit product format: 538081061
Labeler code: 53808
Product ID: 53808-1061_77f11b3f-cb30-432a-aa27-9c9286c91da2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: NDA021168
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-11-01
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: 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	53808-1061		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-1061	53808-1061-1	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 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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`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	53808-1061-1	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021168-001	DEPAKOTE ER	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04
N021168-002	DEPAKOTE ER	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021168-001	AB
N021168-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2000-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021168-001	DEPAKOTE ER	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021168-002	DEPAKOTE ER	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-05-31	`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	N021168-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021168-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021168-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021168-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021168-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021168-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021168-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021168-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021168-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021168-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021168-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021168-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021168-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021168-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021168-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021168-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021168-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021168-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021168-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021168-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021168-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021168-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021168-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021168-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021168-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021168-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021168-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021168-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021168-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021168-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021168-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021168-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021168-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021168-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021168-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021168-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021168-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021168-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021168-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021168-001	6419953*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-001	6511678*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-001	6528090*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-001	6528091*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-001	6713086*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-001	6720004*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-002	6511678*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-002	6528090*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-002	6713086*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021168-002	6720004*PED	2019-06-18	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021168-001	6419953*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-001	6511678*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-001	6528090*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-001	6528091*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-001	6713086*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-001	6720004*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-002	6511678*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-002	6528090*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-002	6713086*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021168-002	6720004*PED	2019-06-18	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021168-001	6419953*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-001	6511678*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-001	6528090*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-001	6528091*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-001	6713086*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-001	6720004*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-002	6511678*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-002	6528090*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-002	6713086*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021168-002	6720004*PED	2019-06-18	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021168-001	6419953*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-001	6511678*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-001	6528090*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-001	6528091*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-001	6713086*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-001	6720004*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-002	6511678*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-002	6528090*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-002	6713086*PED	2019-06-18	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021168-002	6720004*PED	2019-06-18	Pediatric extension	`ea99ee380514…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1061-1	2020-01-31	C162847	48780-1	9d75b9d0-6619-f424-e053-dadaa90a57ce	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 for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1061-1	Divalproex Sodium Extended-Release	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED 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
53808-1061	DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20150107_01c035ee-6bed-431d-9324-e0e0bc507eae.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depakote ER	DIVALPROEX SODIUM	AbbVie Inc.	0dc024ce-efc8-4690-7cb5-639c728fccac	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021168 application number: NDA021168

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	01c035ee-6bed-431d-9324-e0e0bc507eae	1
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	01c035ee-6bed-431d-9324-e0e0bc507eae	1
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	01c035ee-6bed-431d-9324-e0e0bc507eae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-1061-1	53808106101	30 in 1 BLISTER PACK	Historical

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