FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
67046-150
11-digit product format
670460150
Labeler code
67046
Product ID
67046-150_59b80d0d-6a54-440a-e053-2991aa0ae8e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA203730
Marketing category
ANDA
Marketing start
2017-09-21
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
67046-150-072020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-142020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-152020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-202020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-212020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-282020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-302020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000
67046-150-602020-01-31C16284748780-19d75b9d0-e488-f424-e053-dadaa90a57ce150 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, USP for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-150-07Divalproex Sodium7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE71
67046-150-14Divalproex Sodium14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE141
67046-150-15Divalproex Sodium15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE151
67046-150-20Divalproex Sodium20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE201
67046-150-21Divalproex Sodium21 in 1 BLISTER PACKTABLET, EXTENDED RELEASE211
67046-150-28Divalproex Sodium28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE281
67046-150-30Divalproex Sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301
67046-150-60Divalproex Sodium60 in 1 BLISTER PACKTABLET, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-150DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b80d0d-6a53-440a-e053-2991aa0ae8e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN59b80d0d-6a53-440a-e053-2991aa0ae8e31
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD59b80d0d-6a53-440a-e053-2991aa0ae8e31
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY59b80d0d-6a53-440a-e053-2991aa0ae8e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-150-07670460150077 in 1 BLISTER PACKHistorical
67046-150-146704601501414 in 1 BLISTER PACKHistorical
67046-150-156704601501515 in 1 BLISTER PACKHistorical
67046-150-206704601502020 in 1 BLISTER PACKHistorical
67046-150-216704601502121 in 1 BLISTER PACKHistorical
67046-150-286704601502828 in 1 BLISTER PACKHistorical
67046-150-306704601503030 in 1 BLISTER PACKHistorical
67046-150-606704601506060 in 1 BLISTER PACKHistorical