Divalproex Sodium

Product NDC
68382-134
Requested package NDC
68382-134-01
11-digit product format
683820134
Labeler code
68382
Product ID
68382-134_1881b0e4-109a-47b2-a1e7-b900da6dcf7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA078239
Marketing category
ANDA
Marketing start
2013-01-07
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-13468382-134-01DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-13468382-134-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-13468382-134-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078239-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27
A078239-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078239-001AB
A078239-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078239-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A078239-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-08-04782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078239-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078239-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078239-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078239-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078239-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078239-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078239-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078239-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078239-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078239-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078239-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078239-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078239-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078239-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078239-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078239-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078239-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078239-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078239-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078239-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078239-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078239-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078239-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078239-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078239-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078239-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078239-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078239-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078239-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078239-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078239-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078239-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078239-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078239-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078239-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078239-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078239-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078239-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078239-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078239-002AB1782e0a99824c…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]14

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaginga8ba3986-1ded-44a8-8d10-d0f252a077942025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078239
application number: ANDA078239
Divalproex SodiumDIVALPROEX SODIUMBluePoint Laboratories1b12c694-e120-45f6-ad28-36373e2c53782025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078239
application number: ANDA078239

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-134-0168382013401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-134-01) 2013-01-070000-00-00NoNoCurrent