Divalproex Sodium

Product NDC: 67296-1677
11-digit product format: 672961677
Labeler code: 67296
Product ID: 67296-1677_b8dfa252-0f9d-9e68-e053-2995a90a7596
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA203730
Marketing category: ANDA
Marketing start: 2019-01-01
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: 2022-12-31
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	67296-1677		I	Inactivated by FDA		2026-08-17
excluded package	package	67296-1677	67296-1677-1	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 · 30 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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`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	67296-1677-1	`1332a3947898…`	`d4bfe170f9cd…`

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
A203730-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29
A203730-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203730-001	AB
A203730-002	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	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203730-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203730-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2015-05-29	`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	A203730-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203730-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203730-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203730-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203730-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203730-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203730-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203730-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203730-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203730-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203730-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203730-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203730-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203730-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203730-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203730-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203730-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203730-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203730-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203730-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203730-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203730-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203730-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203730-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203730-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203730-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203730-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203730-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203730-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203730-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203730-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203730-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203730-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203730-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203730-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203730-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203730-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203730-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203730-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203730-002	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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1677-1	2023-01-30	C162847	48780-1	f386c649-c116-0266-e053-dadaa90a7c1a	Divalproex ER 250mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1677-1	Divalproex Sodium	10 in 1 BOTTLE	TABLET, EXTENDED RELEASE	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1677	DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [REDPHARM DRUG, INC.]	6	Legacy NDC, 1 package rows	20210115_8918ee32-2f03-72d9-e053-2a95a90a51ee.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	33f07aac-4dc5-4f97-976a-a84f93497bc6	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203730 application number: ANDA203730
Divalproex Sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	3b41cd15-9981-4d44-9c4b-e84168d86453	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203730 application number: ANDA203730
Divalproex Sodium	DIVALPROEX SODIUM	Cardinal Health 107, LLC	283af6d2-8ea2-4225-b2e7-a2057dbdb793	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203730 application number: ANDA203730
Divalproex Sodium	DIVALPROEX SODIUM	Amneal Pharmaceuticals LLC	7d3352ee-a240-43ff-a243-29ad2bc989c7	2026-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203730 application number: ANDA203730
Divalproex Sodium	DIVALPROEX SODIUM	Major Pharmaceuticals	ef472176-7f98-4f88-be5e-a101fecb46fd	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203730 application number: ANDA203730
Divalproex Sodium	DIVALPROEX SODIUM	AvPAK	e8cc336b-5191-7f8b-e053-2a95a90a6acb	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203730 application number: ANDA203730

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
644VL95AO6	DIVALPROEX SODIUM	76584-70-8	DIVALPROEX SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	8918ee32-2f03-72d9-e053-2a95a90a51ee	6
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	8918ee32-2f03-72d9-e053-2a95a90a51ee	6
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	8918ee32-2f03-72d9-e053-2a95a90a51ee	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1677-1	67296167701	10 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1677-1)	2019-01-01	0000-00-00	No	No	Current