DIVALPROEX SODIUM

Product NDC: 61919-249
11-digit product format: 619190249
Labeler code: 61919
Product ID: 61919-249_4d3b1fe0-aac6-600d-e063-6394a90a4a87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: DirectRx
Application: ANDA079163
Marketing category: ANDA
Marketing start: 2022-04-06
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: 2027-12-31
Current FDA listing: Yes

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-249-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-249-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-249-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-249-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-249-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-249-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-249-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-249-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-249-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-249-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-249-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-249-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-249-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-249-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-249-60	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-249-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-249-60	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-249-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-249-60	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-249-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-249-60	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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
A079163-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05
A079163-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05
A079163-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079163-001	AB
A079163-002	AB
A079163-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079163-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079163-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079163-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2011-04-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079163-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079163-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079163-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079163-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079163-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079163-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079163-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079163-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079163-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079163-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079163-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079163-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079163-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079163-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079163-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079163-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079163-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079163-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079163-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079163-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079163-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079163-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079163-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079163-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079163-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079163-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079163-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079163-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079163-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079163-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079163-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079163-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079163-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079163-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079163-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079163-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079163-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079163-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079163-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079163-001	AB	1	`8072bd15b7f6…`

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	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
644VL95AO6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099870	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ce12c7b1-caa9-4224-bb5f-3e20e0281d66	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61919-249-60	2025-01-30	DIVALPROEX SODIUM
61919-249-30	2022-04-20	DIVALPROEX SODIUM
61919-249-60	2022-04-20	DIVALPROEX SODIUM
61919-249-30	2020-01-31	DIVALPROEX SODIUM
61919-249-60	2020-01-31	DIVALPROEX SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-249-30	DIVALPROEX SODIUM	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30		4
61919-249-60	DIVALPROEX SODIUM	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-249-30	EA - Each	61919-249	8492a19f-fff9-46a8-8e8a-10e763164401	1	2016-09-02
61919-249-60	EA - Each	61919-249	503093bc-4800-4ad2-935d-a5dd31cd4798	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1
VANILLIN	INACTIVE INGREDIENT	CHI530446X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-249	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DIRECTRX]	2	Current NDC, Legacy NDC, 2 package rows	20220421_ce12c7b1-caa9-4224-bb5f-3e20e0281d66.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	Unit Dose Solutions, Inc.	547d8305-bfc5-f4da-e063-6294a90a6106	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	beba3da1-e80d-45b4-9bd6-3ed85c9482f3	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	BluePoint Laboratories	b95494e2-ee7a-7415-e053-2995a90ae852	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Unichem Pharmaceuticals (USA), Inc.	1ec1a441-218a-4c80-a0cb-69bcc327f472	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
DIVALPROEX SODIUM	DIVALPROEX SODIUM	DirectRx	ce12c7b1-caa9-4224-bb5f-3e20e0281d66	2026-03-17	Warnings	Exact identifier application applno (ANDA): 079163 application number: ANDA079163 ndc (product): 61919-249
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	c8f84c2e-5621-4435-8023-b4e090f7af02	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Northwind Health Company, LLC	ab6fa448-7485-6644-e053-2a95a90aa181	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	1107f190-bef1-41cb-9393-8479b0a56040	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	71296464-0c09-4ff2-beb3-377af77dc4cf	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	79e6dc26-a38b-4642-a216-1fa1213b919a	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	d67af03a-5261-4358-8787-2e729267ff7e	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	ca6bbec6-5631-4436-957e-fb8707e1683d	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	c8d9cd69-ceca-3057-9d1c-12c44b19f767	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0fb57229-08ef-44d6-b40a-92b2f96ff795	2025-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	8ecfe765-d743-4308-9cd9-4a7b1a229ea9	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	A-S Medication Solutions	c3af30e3-27ff-4285-8e4a-81856f266b32	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163
Divalproex Sodium	DIVALPROEX SODIUM	Proficient Rx LP	abac11e6-7ce1-491c-9ac3-61f3df54c4a4	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079163 application number: ANDA079163

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
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	PSN	ce12c7b1-caa9-4224-bb5f-3e20e0281d66	4
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	SCD	ce12c7b1-caa9-4224-bb5f-3e20e0281d66	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-249-30	61919024930	30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-249-30)	2022-04-06		No	No	Current
61919-249-60	61919024960	60 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-249-60)	2022-04-06	0000-00-00	No	No	Current