FDA.reportPublic FDA data

Depakote

Product NDC
21695-163
11-digit product format
216950163
Labeler code
21695
Product ID
21695-163_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021168
Marketing category
NDA
Marketing start
2010-06-07
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-163-152019-09-24C16284748780-1934fe258-4803-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Depakote ER safely and effectively. See full prescribing information for Depakote ER. Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-163-15Depakote15 in 1 BOTTLETABLET, EXTENDED RELEASE151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-163-15EA - Each21695-163c3fdaf3f-070f-4804-8fe0-bc35dc5c3e3212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-163DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110525_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099565Depakote ER 250 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099571Depakote ER 500 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956524 HR divalproex sodium 250 MG Extended Release Oral Tablet [Depakote]SBDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109957124 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote]SBDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956524 HR Depakote 250 MG Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109957124 HR Depakote 500 MG Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099565Depakote 250 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099571Depakote 500 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-163-152169501631515 in 1 BOTTLEHistorical