Divalproex Sodium

Product NDC: 68001-106
11-digit product format: 680010106
Labeler code: 68001
Product ID: 68001-106_304dd980-5e9b-d776-e063-6394a90aa9cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA078239
Marketing category: ANDA
Marketing start: 2013-10-08
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078239-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-02-27
A078239-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB		2009-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078239-001	AB
A078239-002	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 · 82 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	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078239-001	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078239-002	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE / ORAL	AB	2009-08-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078239-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078239-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078239-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078239-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078239-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078239-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078239-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078239-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078239-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078239-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078239-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078239-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078239-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078239-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078239-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078239-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078239-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078239-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078239-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078239-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078239-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078239-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078239-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078239-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078239-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078239-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078239-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078239-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078239-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099563	Internal RxNorm lookup
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
1b12c694-e120-45f6-ad28-36373e2c5378	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-106-00	Divalproex Sodium	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		30
68001-106-03	Divalproex Sodium	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-106-00	EA - Each	68001-106	36cc1d2f-0fc8-4c65-b48a-ff46b8bde574	1	2013-12-02
68001-106-03	EA - Each	68001-106	ea6b98c5-3b3b-4351-b2da-2cee178a3af9	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	10
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-106	DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	30	Current NDC, Legacy NDC, 2 package rows	20250316_1b12c694-e120-45f6-ad28-36373e2c5378.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Divalproex Sodium	DIVALPROEX SODIUM	American Health Packaging	a8ba3986-1ded-44a8-8d10-d0f252a07794	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078239 application number: ANDA078239
Divalproex Sodium	DIVALPROEX SODIUM	BluePoint Laboratories	1b12c694-e120-45f6-ad28-36373e2c5378	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078239 application number: ANDA078239 ndc (product): 68001-106

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	1b12c694-e120-45f6-ad28-36373e2c5378	30
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	1b12c694-e120-45f6-ad28-36373e2c5378	30
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	1b12c694-e120-45f6-ad28-36373e2c5378	30
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	1b12c694-e120-45f6-ad28-36373e2c5378	30
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	1b12c694-e120-45f6-ad28-36373e2c5378	30
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	1b12c694-e120-45f6-ad28-36373e2c5378	30
1099563	divalproex sodium 250 MG 24HR Extended Release Oral Tablet	PSN	a8ba3986-1ded-44a8-8d10-d0f252a07794	15
1099569	divalproex sodium 500 MG 24HR Extended Release Oral Tablet	PSN	a8ba3986-1ded-44a8-8d10-d0f252a07794	15
1099563	24 HR divalproex sodium 250 MG Extended Release Oral Tablet	SCD	a8ba3986-1ded-44a8-8d10-d0f252a07794	15
1099569	24 HR divalproex sodium 500 MG Extended Release Oral Tablet	SCD	a8ba3986-1ded-44a8-8d10-d0f252a07794	15
1099563	divalproex sodium 250 MG 24 HR Extended Release Oral Tablet	SY	a8ba3986-1ded-44a8-8d10-d0f252a07794	15
1099569	divalproex sodium 500 MG 24 HR Extended Release Oral Tablet	SY	a8ba3986-1ded-44a8-8d10-d0f252a07794	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-106-00	68001010600	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-00)	2013-10-08	0000-00-00	No	No	Current
68001-106-03	68001010603	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-03)	2013-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex Sodium	American Health Packaging	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	15
Divalproex Sodium	BluePoint Laboratories \| Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Ltd	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	30
Divalproex Sodium	REMEDYREPACK INC.	2019-04-22	HUMAN PRESCRIPTION DRUG LABEL	1