FDA.reportPublic FDA data

Divalproex Sodium Extended-Release

Product NDC
53808-1061
11-digit product format
538081061
Labeler code
53808
Product ID
53808-1061_77f11b3f-cb30-432a-aa27-9c9286c91da2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021168
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-11-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1061-12020-01-31C16284748780-19d75b9d0-6619-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use divalproex sodium extended-release tablets safely and effectively. See full prescribing information for divalproex sodium extended-release tablets. Divalproex sodium extended-release tablets for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1061-1Divalproex Sodium Extended-Release30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1061DIVALPROEX SODIUM EXTENDED-RELEASE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20150107_01c035ee-6bed-431d-9324-e0e0bc507eae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN01c035ee-6bed-431d-9324-e0e0bc507eae1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD01c035ee-6bed-431d-9324-e0e0bc507eae1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY01c035ee-6bed-431d-9324-e0e0bc507eae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1061-15380810610130 in 1 BLISTER PACKHistorical