FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
67046-105
11-digit product format
670460105
Labeler code
67046
Product ID
67046-105_59b94f04-42a1-2100-e053-2991aa0ab8f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA078597
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
2020-12-31
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-105-072022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-142022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-152022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-202022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-212022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-282022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-302022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-602022-01-28C16284748780-1d6a99b39-689e-a426-e053-dadaa90af4c2145 Divalproex DR 250 mg 105 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
67046-105-07Divalproex Sodium7 in 1 BLISTER PACKTABLET, DELAYED RELEASE71
67046-105-14Divalproex Sodium14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
67046-105-15Divalproex Sodium15 in 1 BLISTER PACKTABLET, DELAYED RELEASE151
67046-105-20Divalproex Sodium20 in 1 BLISTER PACKTABLET, DELAYED RELEASE201
67046-105-21Divalproex Sodium21 in 1 BLISTER PACKTABLET, DELAYED RELEASE211
67046-105-28Divalproex Sodium28 in 1 BLISTER PACKTABLET, DELAYED RELEASE281
67046-105-30Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301
67046-105-60Divalproex Sodium60 in 1 BLISTER PACKTABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-105DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170922_59b94f04-42a0-2100-e053-2991aa0ab8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN59b94f04-42a0-2100-e053-2991aa0ab8f11
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN59b94f04-42a0-2100-e053-2991aa0ab8f11
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD59b94f04-42a0-2100-e053-2991aa0ab8f11
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD59b94f04-42a0-2100-e053-2991aa0ab8f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-105-07670460105077 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-07) 2017-09-210000-00-00NoNoCurrent
67046-105-146704601051414 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-14) 2017-09-210000-00-00NoNoCurrent
67046-105-156704601051515 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-15) 2017-09-210000-00-00NoNoCurrent
67046-105-206704601052020 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-20) 2017-09-210000-00-00NoNoCurrent
67046-105-216704601052121 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-21) 2017-09-210000-00-00NoNoCurrent
67046-105-286704601052828 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-28) 2017-09-210000-00-00NoNoCurrent
67046-105-306704601053030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-30) 2017-09-210000-00-00NoNoCurrent
67046-105-606704601056060 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-105-60) 2017-09-210000-00-00NoNoCurrent