Divalproex Sodium

Product NDC
67046-122
11-digit product format
670460122
Labeler code
67046
Product ID
67046-122_a24e8e53-07b3-49be-87e4-124f7d3aeac1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077567
Marketing category
ANDA
Marketing start
2010-08-18
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
E
Listing certified through
2017-12-31
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
67046-122-30Divalproex 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 [CONTRACT PHARMACY SERVICES-PA]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-122DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100819_a24e8e53-07b3-49be-87e4-124f7d3aeac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNa24e8e53-07b3-49be-87e4-124f7d3aeac11
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDa24e8e53-07b3-49be-87e4-124f7d3aeac11
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYa24e8e53-07b3-49be-87e4-124f7d3aeac11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-122-306704601223030 in 1 BLISTER PACKHistorical