Divalproex Sodium

Product NDC
53808-0831
11-digit product format
538080831
Labeler code
53808
Product ID
53808-0831_970a776f-2cac-4d2e-be54-e10a3af85ec4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077567
Marketing category
ANDA
Marketing start
2013-01-01
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
2019-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0831-1Divalproex Sodium30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0831DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140408_326fc363-f0c6-4469-ba37-9b93ecb08da1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN326fc363-f0c6-4469-ba37-9b93ecb08da11
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD326fc363-f0c6-4469-ba37-9b93ecb08da11
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY326fc363-f0c6-4469-ba37-9b93ecb08da11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0831-15380808310130 in 1 BLISTER PACKHistorical