FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
21695-818
11-digit product format
216950818
Labeler code
21695
Product ID
21695-818_9b3db659-f64c-4c48-946a-6b4f1d800eba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078790
Marketing category
ANDA
Marketing start
2009-10-14
Marketing end
0000-00-00
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-818-602019-09-24C16284748780-1934fe258-49dd-48b1-e053-8cdaa90a720aDivalproex Sodium Delayed-Release Tablets USP 125 mg, 250 mg and 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-818-60Divalproex SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-818-60EA - Each21695-818819b2db1-775e-4f94-ad95-2c14be67ebb012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-818DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110429_9b3db659-f64c-4c48-946a-6b4f1d800eba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD9b3db659-f64c-4c48-946a-6b4f1d800eba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-818-602169508186060 in 1 BOTTLEHistorical