FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
67046-146
11-digit product format
670460146
Labeler code
67046
Product ID
67046-146_5a92534c-5787-af98-e053-2991aa0aa8ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090070
Marketing category
ANDA
Marketing start
2017-10-02
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
67046-146-072020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-142020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-152020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-202020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-212020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-282020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-302020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-602020-01-31C16284748780-19d75b9d1-103b-f424-e053-dadaa90a57ce146 Divalproex ER 500 mg These 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
67046-146-07Divalproex Sodium7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE71
67046-146-14Divalproex Sodium14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE141
67046-146-15Divalproex Sodium15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE151
67046-146-20Divalproex Sodium20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE201
67046-146-21Divalproex Sodium21 in 1 BLISTER PACKTABLET, EXTENDED RELEASE211
67046-146-28Divalproex Sodium28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE281
67046-146-30Divalproex Sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301
67046-146-60Divalproex Sodium60 in 1 BLISTER PACKTABLET, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-146DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171002_5a92253f-a665-afe2-e053-2991aa0a90cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN5a92253f-a665-afe2-e053-2991aa0a90cd1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD5a92253f-a665-afe2-e053-2991aa0a90cd1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY5a92253f-a665-afe2-e053-2991aa0a90cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-146-07670460146077 in 1 BLISTER PACKHistorical
67046-146-146704601461414 in 1 BLISTER PACKHistorical
67046-146-156704601461515 in 1 BLISTER PACKHistorical
67046-146-206704601462020 in 1 BLISTER PACKHistorical
67046-146-216704601462121 in 1 BLISTER PACKHistorical
67046-146-286704601462828 in 1 BLISTER PACKHistorical
67046-146-306704601463030 in 1 BLISTER PACKHistorical
67046-146-606704601466060 in 1 BLISTER PACKHistorical