FDA.reportPublic FDA data

Divalproex sodium

Product NDC
50090-4737
11-digit product format
500904737
Labeler code
50090
Product ID
50090-4737_25e51f5b-404b-4453-a521-b98bf0469b75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
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
Rxcui1099569

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
50090-4737-02023-08-24C16284748780-1f386c649-9fb8-0266-e053-dadaa90a7c1aThese 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
50090-4737-12023-08-24C16284748780-1f386c649-9fb8-0266-e053-dadaa90a7c1aThese 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
50090-4737-02023-01-30C16284748780-1f386c649-9fb8-0266-e053-dadaa90a7c1aThese 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
50090-4737-12023-01-30C16284748780-1f386c649-9fb8-0266-e053-dadaa90a7c1aThese 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
50090-4737-0Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011
50090-4737-1Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4737DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240501_94eac383-a89f-4128-b81c-076640b8edcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN94eac383-a89f-4128-b81c-076640b8edcf11
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD94eac383-a89f-4128-b81c-076640b8edcf11
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY94eac383-a89f-4128-b81c-076640b8edcf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4737-05009047370030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4737-0) 2019-11-200000-00-00NoNoCurrent
50090-4737-15009047370190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4737-1) 2019-11-200000-00-00NoNoCurrent