FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
68151-4162
11-digit product format
681514162
Labeler code
68151
Product ID
68151-4162_8293c8a8-354f-4be2-8ee5-e90c71d1b1d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA079163
Marketing category
ANDA
Marketing start
2011-10-01
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
E
Listing certified through
2018-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
68151-4162-72020-01-31C16284748780-19d75b9d1-0e9d-f424-e053-dadaa90a57ceThese 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
68151-4162-7Divalproex Sodium1 in 1 CUP, UNIT-DOSETABLET, DELAYED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4162DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160311_485123a6-15c2-48f8-9ec5-3287f3effb3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN485123a6-15c2-48f8-9ec5-3287f3effb3a2
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD485123a6-15c2-48f8-9ec5-3287f3effb3a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4162-7681514162071 in 1 CUP, UNIT-DOSEHistorical