Application 078182

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 125MG VALPROIC ACID	No	No
002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	No
003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 500MG VALPROIC ACID	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078182-001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29
A078182-002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29
A078182-003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078182-001	AB
A078182-002	AB
A078182-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078182-002	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078182-003	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078182-001	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE / ORAL	AB	2008-07-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078182-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078182-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078182-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078182-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078182-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078182-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078182-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078182-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078182-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078182-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078182-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078182-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078182-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078182-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078182-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078182-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078182-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078182-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078182-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078182-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078182-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078182-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078182-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078182-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078182-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078182-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078182-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078182-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078182-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078182-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078182-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078182-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078182-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078182-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078182-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078182-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078182-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078182-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078182-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078182-001	AB	1	`1e350fbaab3a…`

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 · 4 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	4fc50afb-67f3-4bf3-9ec3-cc12734f47fd	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078182 application number: ANDA078182 ndc (product): 55154-5633
Divalproex Sodium	DIVALPROEX SODIUM	Upsher-Smith Laboratories, LLC	02304a23-4a5f-47bc-9687-4044b43f7a20	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078182 application number: ANDA078182 ndc (product): 0832-7122 ndc (product): 0832-7123 ndc (product): 0832-7124
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	b74adc5e-e92d-46a7-afdc-a6464a440bde	2018-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078182 application number: ANDA078182 ndc (product): 71610-031
Divalproex Sodium	DIVALPROEX SODIUM	Aphena Pharma Solutions - Tennessee, LLC	9cfdcb58-d6d7-43bb-b6e1-17172b143296	2018-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078182 application number: ANDA078182 ndc (product): 71610-032

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7531	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7532	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7533	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8326	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8326	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8327	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8327	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8328	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8328	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8328	Divalproex Sodium	Divalproex Sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0832-7122	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7122	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7122	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7122	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7122	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7123	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7123	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7123	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7123	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7123	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7124	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7124	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7124	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7124	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-7124	Divalproex Sodium	Divalproex Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
50090-3416	Divalproex Sodium	Divalproex Sodium	A-S Medication Solutions	ANDA	Current
53808-1027	Divalproex Sodium	Divalproex Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5633	Divalproex Sodium	Divalproex Sodium	Cardinal Health	ANDA	Current
55154-5633	Divalproex Sodium	Divalproex Sodium	Cardinal Health 107, LLC	ANDA	Current
67046-120	Divalproex Sodium	Divalproex Sodium	Contract Pharmacy Services-PA	ANDA	Current
67046-121	Divalproex Sodium	Divalproex Sodium	Contract Pharmacy Services-PA	ANDA	Current
70518-3364	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-3459	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
71610-031	Divalproex Sodium	Divalproex Sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-032	Divalproex Sodium	Divalproex Sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31341	ORIG	2008-08-05