Divalproex Sodium

Product NDC: 29300-138
11-digit product format: 293000138
Labeler code: 29300
Product ID: 29300-138_8e888ed9-2d55-4e95-ba7b-8b437481c947
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Divalproex Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA079163
Marketing category: ANDA
Marketing start: 2011-10-01
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 · 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…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099625	Internal RxNorm lookup
1099678	Internal RxNorm lookup
1099870	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
1ec1a441-218a-4c80-a0cb-69bcc327f472	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
57fc3d01-4737-4091-9728-9e8a4c9e708d	Product name	1	20200121
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
29300-138-01	Divalproex Sodium	100 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	100	26
29300-138-05	Divalproex Sodium	500 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	500	26
29300-138-10	Divalproex Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	1000	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-138-01	EA - Each	29300-138	6b861e62-4fa8-4a39-a0fd-8943913ae911	1	2012-07-24
29300-138-05	EA - Each	29300-138	4af6f12e-1fdd-40b6-8a54-5b63b6c1322f	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 TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
VALPROIC ACID	ACTIVE MOIETY	614OI1Z5WI	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10
VANILLIN	INACTIVE INGREDIENT	CHI530446X	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-138	DIVALPROEX SODIUM TABLET, DELAYED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]	23	Current NDC, Legacy NDC, 3 package rows	20250223_1ec1a441-218a-4c80-a0cb-69bcc327f472.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 · 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 ndc (product): 29300-138
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099625	divalproex sodium 125 MG Delayed Release Oral Tablet	PSN	1ec1a441-218a-4c80-a0cb-69bcc327f472	26
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	PSN	1ec1a441-218a-4c80-a0cb-69bcc327f472	26
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	PSN	1ec1a441-218a-4c80-a0cb-69bcc327f472	26
1099625	divalproex sodium 125 MG Delayed Release Oral Tablet	SCD	1ec1a441-218a-4c80-a0cb-69bcc327f472	26
1099678	divalproex sodium 250 MG Delayed Release Oral Tablet	SCD	1ec1a441-218a-4c80-a0cb-69bcc327f472	26
1099870	divalproex sodium 500 MG Delayed Release Oral Tablet	SCD	1ec1a441-218a-4c80-a0cb-69bcc327f472	26
1099625	divalproex sodium 125 MG Delayed Release Oral Tablet	PSN	c3af30e3-27ff-4285-8e4a-81856f266b32	9
1099625	divalproex sodium 125 MG Delayed Release Oral Tablet	SCD	c3af30e3-27ff-4285-8e4a-81856f266b32	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-138-01	29300013801	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-138-01)	2011-10-01	0000-00-00	No	No	Current
29300-138-05	29300013805	500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-138-05)	2011-10-01	0000-00-00	No	No	Current
29300-138-10	29300013810	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (29300-138-10)	2011-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Divalproex Sodium	Unichem Pharmaceuticals (USA), Inc. \| Unichem Laboratories Limited, India \| Unichem Laboratories Limited	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	26
Divalproex Sodium	REMEDYREPACK INC.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	6
Divalproex Sodium	A-S Medication Solutions	2024-04-23	HUMAN PRESCRIPTION DRUG LABEL	9
Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	2019-10-29	HUMAN PRESCRIPTION DRUG LABEL	2