FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
67046-138
11-digit product format
670460138
Labeler code
67046
Product ID
67046-138_5a04ccc6-8e81-59d6-e053-2a91aa0a67b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077100
Marketing category
ANDA
Marketing start
2017-09-25
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
67046-138-072020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-142020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-152020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-202020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-212020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-282020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-302020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983
67046-138-602020-01-31C16284748780-19d75b9d0-8d8b-f424-e053-dadaa90a57ce137 Divalproex DR 250 mg 138 Divalproex DR 500 mg These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE tablets, for oral use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-138-07Divalproex Sodium7 in 1 BLISTER PACKTABLET, DELAYED RELEASE71
67046-138-14Divalproex Sodium14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
67046-138-15Divalproex Sodium15 in 1 BLISTER PACKTABLET, DELAYED RELEASE151
67046-138-20Divalproex Sodium20 in 1 BLISTER PACKTABLET, DELAYED RELEASE201
67046-138-21Divalproex Sodium21 in 1 BLISTER PACKTABLET, DELAYED RELEASE211
67046-138-28Divalproex Sodium28 in 1 BLISTER PACKTABLET, DELAYED RELEASE281
67046-138-30Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301
67046-138-60Divalproex Sodium60 in 1 BLISTER PACKTABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-138DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170925_5a04ccc6-8e80-59d6-e053-2a91aa0a67b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN5a04ccc6-8e80-59d6-e053-2a91aa0a67b71
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN5a04ccc6-8e80-59d6-e053-2a91aa0a67b71
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD5a04ccc6-8e80-59d6-e053-2a91aa0a67b71
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD5a04ccc6-8e80-59d6-e053-2a91aa0a67b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-138-07670460138077 in 1 BLISTER PACKHistorical
67046-138-146704601381414 in 1 BLISTER PACKHistorical
67046-138-156704601381515 in 1 BLISTER PACKHistorical
67046-138-206704601382020 in 1 BLISTER PACKHistorical
67046-138-216704601382121 in 1 BLISTER PACKHistorical
67046-138-286704601382828 in 1 BLISTER PACKHistorical
67046-138-306704601383030 in 1 BLISTER PACKHistorical
67046-138-606704601386060 in 1 BLISTER PACKHistorical