FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
51079-766
11-digit product format
510790766
Labeler code
51079
Product ID
51079-766_4358cbe3-b1da-4ab0-e063-6394a90afa64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-02-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-766-01Divalproex Sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE122
51079-766-08Divalproex Sodium80 in 1 CARTONTABLET, FILM COATED, EXTENDED RE8022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-766-01EA - Each51079-766612b3f32-8603-4cb3-af8b-6a2d2cc4bfcb12012-07-24
51079-766-08EA - Each51079-766da97a415-3e21-472b-acac-d9c3ce80234e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
51079-766DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]20Current NDC, Legacy NDC, 2 package rows20231228_b367d81d-4eca-4e28-b490-34be4c003561.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-766-01510790766011 in 1 BLISTER PACKHistorical
51079-766-085107907660880 BLISTER PACK in 1 CARTON (51079-766-08) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-766-01) 80 blister pack2009-02-030000-00-00NoNoCurrent