Divalproex Sodium

Product NDC: 65841-635
Requested package NDC: 65841-635-05
11-digit product format: 658410635
Labeler code: 65841
Product ID: 65841-635_5804b926-b453-429e-90ff-7b73e437afe9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA077100
Marketing category: ANDA
Marketing start: 2010-03-06
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65841-635	65841-635-05	D	Discontinued by firm		2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-635	65841-635-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-635	65841-635-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077100-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05
A077100-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05
A077100-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077100-001	AB
A077100-002	AB
A077100-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077100-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077100-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077100-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2009-03-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077100-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077100-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077100-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077100-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077100-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077100-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077100-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077100-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077100-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077100-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077100-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077100-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077100-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077100-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077100-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077100-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077100-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077100-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077100-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077100-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077100-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077100-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077100-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077100-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077100-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077100-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077100-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077100-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077100-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077100-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077100-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077100-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077100-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077100-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077100-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077100-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077100-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077100-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077100-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077100-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CADILA HEALTHCARE LIMITED]	2

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
65841-635-05	65841063505	500 TABLET, DELAYED RELEASE in 1 BOTTLE (65841-635-05)	2010-03-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely	Zydus Lifesciences Limited	2024-11-28	HUMAN PRESCRIPTION DRUG LABEL	10