FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
67046-147
11-digit product format
670460147
Labeler code
67046
Product ID
67046-147_5a050880-e41b-4d54-e053-2991aa0a6da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA079163
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
DIVALPROEX SODIUM
Active strength
250 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
67046-147-072022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-142022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-152022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-202022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-212022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-282022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-302022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983
67046-147-602022-01-28C16284748780-1d6a99b39-68a7-a426-e053-dadaa90af4c2147 Divalproex DR 250 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, USP for oral use. Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-147-07Divalproex Sodium7 in 1 BLISTER PACKTABLET, DELAYED RELEASE71
67046-147-14Divalproex Sodium14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
67046-147-15Divalproex Sodium15 in 1 BLISTER PACKTABLET, DELAYED RELEASE151
67046-147-20Divalproex Sodium20 in 1 BLISTER PACKTABLET, DELAYED RELEASE201
67046-147-21Divalproex Sodium21 in 1 BLISTER PACKTABLET, DELAYED RELEASE211
67046-147-28Divalproex Sodium28 in 1 BLISTER PACKTABLET, DELAYED RELEASE281
67046-147-30Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301
67046-147-60Divalproex Sodium60 in 1 BLISTER PACKTABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-147DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170925_5a050880-e41a-4d54-e053-2991aa0a6da6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN5a050880-e41a-4d54-e053-2991aa0a6da61
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD5a050880-e41a-4d54-e053-2991aa0a6da61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-147-07670460147077 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-07) 2017-09-250000-00-00NoNoCurrent
67046-147-146704601471414 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-14) 2017-09-250000-00-00NoNoCurrent
67046-147-156704601471515 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-15) 2017-09-250000-00-00NoNoCurrent
67046-147-206704601472020 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-20) 2017-09-250000-00-00NoNoCurrent
67046-147-216704601472121 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-21) 2017-09-250000-00-00NoNoCurrent
67046-147-286704601472828 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-28) 2017-09-250000-00-00NoNoCurrent
67046-147-306704601473030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-30) 2017-09-250000-00-00NoNoCurrent
67046-147-606704601476060 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-147-60) 2017-09-250000-00-00NoNoCurrent