FDA.reportPublic FDA data

Divalproex sodium

Product NDC
16714-485
11-digit product format
167140485
Labeler code
16714
Product ID
16714-485_ef1358b1-4134-47e7-a61a-12fae692225f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex sodium
Listing expiration
2026-12-31

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
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
16714-485-01Divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10018
16714-485-02Divalproex sodium500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-485-01EA - Each16714-485f93f4001-5a02-433f-a7dd-a7a70c581d9912016-02-04
16714-485-02EA - Each16714-4856376382d-acb2-4d5e-928a-040c684ca97c12016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-485DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [NORTHSTAR RX LLC]17Current NDC, Legacy NDC, 2 package rows20250330_aab6b411-11e9-4a16-afb6-d471ba4756e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNaab6b411-11e9-4a16-afb6-d471ba4756e918
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNaab6b411-11e9-4a16-afb6-d471ba4756e918
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDaab6b411-11e9-4a16-afb6-d471ba4756e918
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDaab6b411-11e9-4a16-afb6-d471ba4756e918
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYaab6b411-11e9-4a16-afb6-d471ba4756e918
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYaab6b411-11e9-4a16-afb6-d471ba4756e918
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
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN41e32cd5-1393-4ef1-81cb-8e3795e306823
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD41e32cd5-1393-4ef1-81cb-8e3795e306823
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY41e32cd5-1393-4ef1-81cb-8e3795e306823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-485-0116714048501100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-485-01) 2014-06-020000-00-00NoNoCurrent
16714-485-0216714048502500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-485-02) 2014-06-020000-00-00NoNoCurrent