Divalproex Sodium

Product NDC
67296-1677
11-digit product format
672961677
Labeler code
67296
Product ID
67296-1677_b8dfa252-0f9d-9e68-e053-2995a90a7596
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203730
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-1677-12023-01-30C16284748780-1f386c649-c116-0266-e053-dadaa90a7c1aDivalproex ER 250mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1677-1Divalproex Sodium10 in 1 BOTTLETABLET, EXTENDED RELEASE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1677DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20210115_8918ee32-2f03-72d9-e053-2a95a90a51ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN8918ee32-2f03-72d9-e053-2a95a90a51ee6
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD8918ee32-2f03-72d9-e053-2a95a90a51ee6
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY8918ee32-2f03-72d9-e053-2a95a90a51ee6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1677-16729616770110 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1677-1) 2019-01-010000-00-00NoNoCurrent