FDA.reportPublic FDA data

DIVALPROEX SODIUM

Product NDC
55648-725
11-digit product format
556480725
Labeler code
55648
Product ID
55648-725_f8aa46d8-270b-48ea-95fc-5febb7b8ddab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIVALPROEX SODIUM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078705
Marketing category
ANDA
Marketing start
2009-08-04
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
2018-12-31
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
55648-725-012020-01-31C16284748780-19d75b9d0-5d61-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
55648-725-022020-01-31C16284748780-19d75b9d0-5d61-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
55648-725-032020-01-31C16284748780-19d75b9d0-5d61-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
55648-725-042020-01-31C16284748780-19d75b9d0-5d61-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
55648-725-01DIVALPROEX SODIUMER30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
55648-725-02DIVALPROEX SODIUMER100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001
55648-725-03DIVALPROEX SODIUMER500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001
55648-725-04DIVALPROEX SODIUMER10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE101
55648-725-04DIVALPROEX SODIUMER10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM ER (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM ER (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-725DIVALPROEX SODIUM ER (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20100723_da69287c-2f37-4299-b444-914c1ab0054c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNda69287c-2f37-4299-b444-914c1ab0054c1
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNda69287c-2f37-4299-b444-914c1ab0054c1
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDda69287c-2f37-4299-b444-914c1ab0054c1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDda69287c-2f37-4299-b444-914c1ab0054c1
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYda69287c-2f37-4299-b444-914c1ab0054c1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYda69287c-2f37-4299-b444-914c1ab0054c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-725-015564807250130 in 1 BOTTLEHistorical
55648-725-0255648072502100 in 1 BOTTLEHistorical
55648-725-0355648072503500 in 1 BOTTLEHistorical
55648-725-045564807250410 in 1 CARTONHistorical