divalproex sodium

Product NDC: 17856-0109
Requested package NDC: 17856-0109-1
11-digit product format: 178560109
Labeler code: 17856
Product ID: 17856-0109_387b221c-08a3-7861-e063-6294a90a1f4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA078919
Marketing category: ANDA
Marketing start: 2019-01-31
Substance: DIVALPROEX SODIUM
Active strength: 125 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 · 13 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078919-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078919-001	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 2 · 42 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	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A078919-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078919-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078919-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078919-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078919-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078919-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078919-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078919-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078919-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078919-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078919-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078919-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078919-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078919-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078919-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078919-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078919-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078919-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078919-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078919-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078919-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078919-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078919-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078919-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078919-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078919-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078919-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078919-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078919-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078919-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078919-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078919-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078919-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078919-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078919-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078919-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078919-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078919-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078919-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078919-001	AB	1	`e64feba35796…`

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	125 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
1099596	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
699a9722-27bd-4e90-819b-d4ecb99466c8	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0109-1	2025-03-31	C162847	48780-1	f386c649-d70b-0266-e053-dadaa90a7c1a	DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE). DIVALPROEX SODIUM delayed-release capsules (sprinkle), for oral use Initial U.S. Approval: 1989
17856-0109-1	2023-01-30	C162847	48780-1	f386c649-d70b-0266-e053-dadaa90a7c1a	DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES (SPRINKLE). DIVALPROEX SODIUM delayed-release capsules (sprinkle), for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0109-1	divalproex sodium	100 in 1 BOX	CAPSULE, COATED PELLETS	100		4
17856-0109-1	divalproex sodium	1 in 1 POUCH	CAPSULE, COATED PELLETS	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0109	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ATLANTIC BIOLOGICALS CORP.]	3	Current NDC, Legacy NDC, 2 package rows	20250402_699a9722-27bd-4e90-819b-d4ecb99466c8.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	Cardinal Health 107, LLC	8e86a610-45ef-4be7-a3ab-f656f5b32706	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919
divalproex sodium	DIVALPROEX SODIUM	REMEDYREPACK INC.	ab8616a5-ea72-4df7-b095-54ea19ef6fba	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919
divalproex sodium	DIVALPROEX SODIUM	Zydus Pharmaceuticals USA Inc.	ed710c62-8ba6-4f19-b240-3ee73cd03d67	2026-04-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919
divalproex sodium	DIVALPROEX SODIUM	ATLANTIC BIOLOGICALS CORP.	699a9722-27bd-4e90-819b-d4ecb99466c8	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919 ndc (package): 17856-0109-1 ndc (product): 17856-0109 ndc11 (package): 17856010901
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	2e4778d8-8798-4da1-bb33-1aa1414b5809	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078919 application number: ANDA078919
divalproex sodium	DIVALPROEX SODIUM	Zydus Lifesciences Limited	b0f33792-dd96-40cc-a28e-acdcdca2f4b8	2024-11-28		Exact identifier application applno (ANDA): 078919 application number: ANDA078919

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
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	PSN	699a9722-27bd-4e90-819b-d4ecb99466c8	4
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	SCD	699a9722-27bd-4e90-819b-d4ecb99466c8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0109-1	17856010901	100 POUCH in 1 BOX (17856-0109-1) / 1 CAPSULE, COATED PELLETS in 1 POUCH	100 pouch	2021-01-28	0000-00-00	No	No	Current