Divalproex sodium

Product NDC
63629-4698
11-digit product format
636294698
Labeler code
63629
Product ID
63629-4698_dea22c38-1892-442c-a286-197e3d1d6975
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099569

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
63629-4698-12024-05-21C16284748780-19d75b9d0-335b-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
63629-4698-22024-05-21C16284748780-19d75b9d0-335b-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
63629-4698-32024-05-21C16284748780-19d75b9d0-335b-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
63629-4698-12024-01-30C16284748780-19d75b9d0-335b-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
63629-4698-22024-01-30C16284748780-19d75b9d0-335b-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
63629-4698-32024-01-30C16284748780-19d75b9d0-335b-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
63629-4698-1Divalproex sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601012
63629-4698-2Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301012
63629-4698-3Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901012
63629-4698-4Divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4698-1EA - Each63629-4698fe41cc6c-3eb5-40a9-aa73-f1853272cadb12023-09-05
63629-4698-2EA - Each63629-469821662ff0-cb09-4bc9-8d6e-4f0a7865187212023-09-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4698DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 4 package rows20250423_e4a815eb-ea20-482a-bb67-06ab34264515.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNe4a815eb-ea20-482a-bb67-06ab342645151012
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDe4a815eb-ea20-482a-bb67-06ab342645151012
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYe4a815eb-ea20-482a-bb67-06ab342645151012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4698-16362946980160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-1) 2024-05-210000-00-00NoNoCurrent
63629-4698-26362946980230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-2) 2024-05-210000-00-00NoNoCurrent
63629-4698-36362946980390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-3) 2014-06-090000-00-00NoNoCurrent
63629-4698-463629469804100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4698-4) 2014-06-09NoNoCurrent