divalproex sodium

Product NDC: 68382-106
11-digit product format: 683820106
Labeler code: 68382
Product ID: 68382-106_3b089c0e-35d2-40ed-a4ad-7c9c32c391be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: divalproex sodium
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA078919
Marketing category: ANDA
Marketing start: 2009-01-27
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: 2027-12-31
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 · 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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078919-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078919-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: divalproex sodium
Listing expiration: 2027-12-31

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
ed710c62-8ba6-4f19-b240-3ee73cd03d67	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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	SPL version
68382-106-01	divalproex sodium	100 in 1 BOTTLE	CAPSULE, COATED PELLETS	100	32
68382-106-10	divalproex sodium	1000 in 1 BOTTLE	CAPSULE, COATED PELLETS	1000	32
68382-106-30	divalproex sodium	1 in 1 BLISTER PACK	CAPSULE, COATED PELLETS	1	32
68382-106-77	divalproex sodium	100 in 1 CARTON	CAPSULE, COATED PELLETS	100	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-106-01	EA - Each	68382-106	577f5278-da81-46e2-a62f-55fc9b1715c4	1	2012-07-24
68382-106-10	EA - Each	68382-106	46425afc-2d35-4347-a969-20bc96184ab1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	12
DIVALPROEX SODIUM	ACTIVE INGREDIENT	644VL95AO6	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-106	DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS USA INC.]	31	Current NDC, Legacy NDC, 4 package rows	20250523_ed710c62-8ba6-4f19-b240-3ee73cd03d67.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 ndc (product): 68382-106
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
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	ed710c62-8ba6-4f19-b240-3ee73cd03d67	32
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	SCD	ed710c62-8ba6-4f19-b240-3ee73cd03d67	32
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	PSN	ab8616a5-ea72-4df7-b095-54ea19ef6fba	16
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	SCD	ab8616a5-ea72-4df7-b095-54ea19ef6fba	16
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	PSN	2e4778d8-8798-4da1-bb33-1aa1414b5809	12
1099596	divalproex sodium 125 MG Delayed Release Oral Capsule	SCD	2e4778d8-8798-4da1-bb33-1aa1414b5809	12
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
68382-106-01	68382010601	100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-01)		2009-01-27	0000-00-00	No	No	Current
68382-106-10	68382010610	1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-10)		2009-01-27	0000-00-00	No	No	Current
68382-106-30	68382010630	1 in 1 BLISTER PACK						Historical
68382-106-77	68382010677	100 BLISTER PACK in 1 CARTON (68382-106-77) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-106-30)	100 blister pack	2009-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
divalproex sodium	REMEDYREPACK INC.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	16
divalproex sodium	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-04-06	HUMAN PRESCRIPTION DRUG LABEL	32
divalproex sodium	ATLANTIC BIOLOGICALS CORP.	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	4
Divalproex Sodium	American Health Packaging	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	12
divalproex sodium	REMEDYREPACK INC.	2024-04-17	HUMAN PRESCRIPTION DRUG LABEL	8
divalproex sodium	AvPAK	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	7