FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
0378-0473
11-digit product format
003780473
Labeler code
0378
Product ID
0378-0473_346235bd-f9cb-4693-9ad2-d62cbe9c62ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-02-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

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
0378-0473-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-012024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
0378-0473-052024-01-30C16284748780-11030e365-4446-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0473-01Divalproex Sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10039
0378-0473-05Divalproex Sodium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50039

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0473DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]33Current NDC, Legacy NDC, 2 package rows20250228_00332c65-edad-a153-9c78-628931daa732.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN00332c65-edad-a153-9c78-628931daa73239
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN00332c65-edad-a153-9c78-628931daa73239
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD00332c65-edad-a153-9c78-628931daa73239
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD00332c65-edad-a153-9c78-628931daa73239
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY00332c65-edad-a153-9c78-628931daa73239
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY00332c65-edad-a153-9c78-628931daa73239
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNb367d81d-4eca-4e28-b490-34be4c00356122
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDb367d81d-4eca-4e28-b490-34be4c00356122
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDb367d81d-4eca-4e28-b490-34be4c00356122
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNbadc4aa2-c0fa-4220-9a6c-bc05eeaa1c033
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDbadc4aa2-c0fa-4220-9a6c-bc05eeaa1c033
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYbadc4aa2-c0fa-4220-9a6c-bc05eeaa1c033
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN0f5bb45e-836b-48ce-9764-2d50edcb202c2
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD3aec1944-86a1-490c-a734-d9dd3b52c9d62
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD3aec1944-86a1-490c-a734-d9dd3b52c9d62
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD0f5bb45e-836b-48ce-9764-2d50edcb202c2
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY3aec1944-86a1-490c-a734-d9dd3b52c9d62
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY0f5bb45e-836b-48ce-9764-2d50edcb202c2
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNa24e8e53-07b3-49be-87e4-124f7d3aeac11
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN326fc363-f0c6-4469-ba37-9b93ecb08da11
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDa24e8e53-07b3-49be-87e4-124f7d3aeac11
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD326fc363-f0c6-4469-ba37-9b93ecb08da11
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYa24e8e53-07b3-49be-87e4-124f7d3aeac11
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY326fc363-f0c6-4469-ba37-9b93ecb08da11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0473-0100378047301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01) 2009-02-020000-00-00NoNoCurrent
0378-0473-0500378047305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05) 2009-02-020000-00-00NoNoCurrent
0378-0473-770037804737790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-77) 2010-03-300000-00-00NoNoCurrent