Divalproex Sodium

Product NDC: 68788-7183
11-digit product format: 687887183
Labeler code: 68788
Product ID: 68788-7183_940d9c25-3bef-4cc5-9250-4de3bcdb0d67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA079163
Marketing category: ANDA
Marketing start: 2018-07-17
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7183		D	Discontinued by firm	2026-08-07
excluded package	package	68788-7183	68788-7183-3	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7183	68788-7183-6	D	Discontinued by firm	2026-08-07
excluded package	package	68788-7183	68788-7183-9	D	Discontinued by firm	2026-08-07

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
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	68788-7183-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7183-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7183-9	`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	68788-7183-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7183-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7183-9	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7183-3	EA - Each	68788-7183	7c4f04f1-7b9f-4fa5-a5d0-a7d9eb1972a8	1	2018-09-05
68788-7183-6	EA - Each	68788-7183	0272eb85-892b-4604-9e05-4b31112a45c7	1	2018-09-05
68788-7183-9	EA - Each	68788-7183	21bcb457-40b6-49ad-92ff-9d8cda7a3ef4	1	2018-09-05

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7183-3	68788718303	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-7183-3)	2018-07-17	0000-00-00	No	No	Current
68788-7183-6	68788718306	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-7183-6)	2018-07-17	0000-00-00	No	No	Current
68788-7183-9	68788718309	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-7183-9)	2018-07-17	0000-00-00	No	No	Current