Divalproex Sodium

Product NDC
55154-4381
11-digit product format
551544381
Labeler code
55154
Product ID
55154-4381_bf3b4548-2deb-4a7e-9878-e4a694d775c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-02-03
Marketing end
0000-00-00
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-4381DDiscontinued by firm2026-08-17
excluded packagepackage55154-438155154-4381-0DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-4381-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-4381-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55154-4381-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55154-4381-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55154-4381-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55154-4381-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55154-4381-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55154-4381-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55154-4381-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55154-4381-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55154-4381-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55154-4381-0557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077567-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29
A077567-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077567-001AB
A077567-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077567-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077567-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077567-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077567-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077567-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077567-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077567-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077567-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077567-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077567-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077567-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077567-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077567-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077567-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077567-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077567-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077567-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077567-002AB1bb7c543d1eb4…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMMylan Pharmaceuticals Inc.00332c65-edad-a153-9c78-628931daa7322026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMSafecor Health, LLC3aec1944-86a1-490c-a734-d9dd3b52c9d62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMMylan Institutional Inc.b367d81d-4eca-4e28-b490-34be4c0035612025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCbf34dd25-abe3-4587-b481-df052f0854292023-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC0f5bb45e-836b-48ce-9764-2d50edcb202c2023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567