DIVALPROEX SODIUM

Product NDC
55648-973
11-digit product format
556480973
Labeler code
55648
Product ID
55648-973_bf372a2f-7f7c-45dc-963c-083c87feb354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIVALPROEX SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA077296
Marketing category
ANDA
Marketing start
2008-07-31
Marketing end
0000-00-00
Substance
DIVALPROEX SODIUM
Active strength
125 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
55648-973-01DIVALPROEX SODIUM100 in 1 BOTTLETABLET, DELAYED RELEASE1001
55648-973-02DIVALPROEX SODIUM500 in 1 BOTTLETABLET, DELAYED RELEASE5001
55648-973-03DIVALPROEX SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301
55648-973-04DIVALPROEX SODIUM10 in 1 BLISTER PACKTABLET, DELAYED RELEASE101
55648-973-04DIVALPROEX SODIUM100 in 1 CARTONTABLET, DELAYED RELEASE1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2DIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-973DIVALPROEX SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20110215_cdce6a8f-02fc-448c-9a81-3d904e49ef97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNcdce6a8f-02fc-448c-9a81-3d904e49ef971
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNcdce6a8f-02fc-448c-9a81-3d904e49ef971
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNcdce6a8f-02fc-448c-9a81-3d904e49ef971
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDcdce6a8f-02fc-448c-9a81-3d904e49ef971
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDcdce6a8f-02fc-448c-9a81-3d904e49ef971
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDcdce6a8f-02fc-448c-9a81-3d904e49ef971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-973-0155648097301100 in 1 BOTTLEHistorical
55648-973-0255648097302500 in 1 BOTTLEHistorical
55648-973-035564809730330 in 1 BOTTLEHistorical
55648-973-045564809730410 in 1 BLISTER PACKHistorical