FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
0378-0472
11-digit product format
003780472
Labeler code
0378
Product ID
0378-0472_346235bd-f9cb-4693-9ad2-d62cbe9c62ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-01-29
Substance
DIVALPROEX SODIUM
Active strength
250 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

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0378-0472-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0472-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0472-01Divalproex Sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10039
0378-0472-05Divalproex Sodium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0472-01EA - Each0378-0472b6bbc5ce-91cc-44c2-a371-ef799274a7d212012-07-24
0378-0472-05EA - Each0378-04728c34a8f0-b709-419d-8c66-64a1ea2e0f6512012-07-24
0378-0472-77EA - Each0378-04723c6effff-5a2f-48d8-8551-bfec7730edb112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]14
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0472DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]33Current NDC, Legacy NDC, 2 package rows20250228_00332c65-edad-a153-9c78-628931daa732.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN00332c65-edad-a153-9c78-628931daa73239
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN00332c65-edad-a153-9c78-628931daa73239
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD00332c65-edad-a153-9c78-628931daa73239
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD00332c65-edad-a153-9c78-628931daa73239
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY00332c65-edad-a153-9c78-628931daa73239
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY00332c65-edad-a153-9c78-628931daa73239
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNb367d81d-4eca-4e28-b490-34be4c00356122
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDb367d81d-4eca-4e28-b490-34be4c00356122
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDb367d81d-4eca-4e28-b490-34be4c00356122
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYb367d81d-4eca-4e28-b490-34be4c00356122
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNbf34dd25-abe3-4587-b481-df052f0854293
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDbf34dd25-abe3-4587-b481-df052f0854293
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYbf34dd25-abe3-4587-b481-df052f0854293
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN3aec1944-86a1-490c-a734-d9dd3b52c9d62
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD3aec1944-86a1-490c-a734-d9dd3b52c9d62
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY3aec1944-86a1-490c-a734-d9dd3b52c9d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0472-0100378047201100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-01) 2009-01-290000-00-00NoNoCurrent
0378-0472-0500378047205500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-05) 2009-01-290000-00-00NoNoCurrent
0378-0472-770037804727790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-77) 2010-03-300000-00-00NoNoCurrent