Divalproex sodium

Product NDC: 63629-4698
11-digit product format: 636294698
Labeler code: 63629
Product ID: 63629-4698_dea22c38-1892-442c-a286-197e3d1d6975
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202419
Marketing category: ANDA
Marketing start: 2014-06-02
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: 2026-12-31
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 · 8 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
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	63629-4698-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-4698-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-4698-2	`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	63629-4698-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-4698-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-4698-2	`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
A202419-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2014-06-02
A202419-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2014-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202419-001	AB
A202419-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202419-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202419-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2014-06-02	`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	A202419-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202419-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202419-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202419-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202419-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202419-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202419-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202419-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202419-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202419-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202419-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202419-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202419-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202419-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202419-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202419-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202419-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202419-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202419-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202419-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202419-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202419-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202419-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202419-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202419-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202419-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202419-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Divalproex sodium
Listing expiration: 2026-12-31

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
1099569	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
e4a815eb-ea20-482a-bb67-06ab34264515	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
63629-4698-1	2024-05-21	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
63629-4698-2	2024-05-21	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
63629-4698-3	2024-05-21	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
63629-4698-1	2024-01-30	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
63629-4698-2	2024-01-30	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
63629-4698-3	2024-01-30	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	SPL version
63629-4698-1	Divalproex sodium	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	1012
63629-4698-2	Divalproex sodium	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	1012
63629-4698-3	Divalproex sodium	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	1012
63629-4698-4	Divalproex sodium	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4698-1	EA - Each	63629-4698	fe41cc6c-3eb5-40a9-aa73-f1853272cadb	1	2023-09-05
63629-4698-2	EA - Each	63629-4698	21662ff0-cb09-4bc9-8d6e-4f0a78651872	1	2023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM ER (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1001
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM ER (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4698	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1011	Current NDC, Legacy NDC, 4 package rows	20250423_e4a815eb-ea20-482a-bb67-06ab34264515.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex sodium	DIVALPROEX SODIUM	Aurobindo Pharma Limited	6240cee7-6aa8-425c-ba46-f889a640f0fa	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	NorthStar Rx LLC	aab6b411-11e9-4a16-afb6-d471ba4756e9	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	41e32cd5-1393-4ef1-81cb-8e3795e30682	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	7e96b724-5f5f-43cb-8d8b-adff3e1fc779	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	3df910c5-b6f0-4a65-9640-b702ecea49f9	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	A-S Medication Solutions	94eac383-a89f-4128-b81c-076640b8edcf	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	0669ac77-10df-48af-bc42-55e768b69e4f	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	e4a815eb-ea20-482a-bb67-06ab34264515	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419 ndc (product): 63629-4698
Divalproex sodium	DIVALPROEX SODIUM	Bryant Ranch Prepack	8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	9a9f5f24-e421-406f-ac91-d1f964245f54	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	177e34e9-f74d-42aa-8e3c-5fb4f41c2322	2018-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419
Divalproex sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	ad5e8bd8-c923-40f0-a106-55620c4247d7	2018-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202419 application number: ANDA202419

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	e4a815eb-ea20-482a-bb67-06ab34264515	1012
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	e4a815eb-ea20-482a-bb67-06ab34264515	1012
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	e4a815eb-ea20-482a-bb67-06ab34264515	1012

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4698-1	63629469801	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-1)	2024-05-21	0000-00-00	No	No	Current
63629-4698-2	63629469802	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-2)	2024-05-21	0000-00-00	No	No	Current
63629-4698-3	63629469803	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-3)	2014-06-09	0000-00-00	No	No	Current
63629-4698-4	63629469804	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-4)	2014-06-09		No	No	Current