Divalproex sodium

Product NDC
50090-6074
11-digit product format
500906074
Labeler code
50090
Product ID
50090-6074_019f5422-2f98-4b86-8ef5-98e209e90e7a
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6074-0Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
50090-6074-1Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6074DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240612_3df910c5-b6f0-4a65-9640-b702ecea49f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN3df910c5-b6f0-4a65-9640-b702ecea49f98
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD3df910c5-b6f0-4a65-9640-b702ecea49f98
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY3df910c5-b6f0-4a65-9640-b702ecea49f98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6074-05009060740030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-6074-0) 2022-09-140000-00-00NoNoCurrent
50090-6074-15009060740190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-6074-1) 2022-09-140000-00-00NoNoCurrent