FDA.reportPublic FDA data

Divalproex sodium

Product NDC
71610-249
11-digit product format
716100249
Labeler code
71610
Product ID
71610-249_3cb12547-8039-47da-9899-9ac1efb13a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, 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
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
71610-249-30Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
71610-249-53Divalproex sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
71610-249-60Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903
71610-249-70Divalproex sodium120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1203
71610-249-80Divalproex sodium180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-249-53EA - Each71610-2493e6dfa91-a702-4e21-be45-b5bf0d66d91c12019-06-19
71610-249-60EA - Each71610-24903eb1fa1-868e-41c1-9e82-a1c9ce4ff22612019-06-19
71610-249-70EA - Each71610-24936db5873-8fd2-4141-aa6d-a25883b670a412019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-249DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20201113_41e32cd5-1393-4ef1-81cb-8e3795e30682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-249-307161002493030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-30) 2020-09-150000-00-00NoNoCurrent
71610-249-537161002495360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-53) 2019-03-140000-00-00NoNoCurrent
71610-249-607161002496090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-60) 2019-03-140000-00-00NoNoCurrent
71610-249-7071610024970120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-70) 2019-03-140000-00-00NoNoCurrent
71610-249-8071610024980180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-249-80) 2020-10-090000-00-00NoNoCurrent