FDA.reportPublic FDA data

Divalproex sodium

Product NDC
71610-205
11-digit product format
716100205
Labeler code
71610
Product ID
71610-205_4a86282f-831d-4cfe-a814-19a3f544fa85
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
71610-205-30Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
71610-205-53Divalproex sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
71610-205-60Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
71610-205-70Divalproex sodium120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201
71610-205-80Divalproex sodium180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-205-30EA - Each71610-20561fc3695-7c58-4e9d-914f-11a1588a570112019-02-13
71610-205-53EA - Each71610-205cf1c9d46-ea58-4b53-a3e3-716089589a2c12019-02-13
71610-205-60EA - Each71610-2052b0e1ecc-1d5c-4045-9d2e-5ad1b54aceb412019-02-13
71610-205-70EA - Each71610-205dcc19a76-ae08-4905-8c59-2d965a7170a212019-02-13
71610-205-80EA - Each71610-205ef404be5-0023-4788-8fd9-537904423cc212019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-205DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 5 package rows20181221_177e34e9-f74d-42aa-8e3c-5fb4f41c2322.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN177e34e9-f74d-42aa-8e3c-5fb4f41c23221
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD177e34e9-f74d-42aa-8e3c-5fb4f41c23221
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY177e34e9-f74d-42aa-8e3c-5fb4f41c23221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-205-307161002053030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-205-30) 2018-12-130000-00-00NoNoCurrent
71610-205-537161002055360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-205-53) 2018-12-130000-00-00NoNoCurrent
71610-205-607161002056090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-205-60) 2018-12-130000-00-00NoNoCurrent
71610-205-7071610020570120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-205-70) 2018-12-130000-00-00NoNoCurrent
71610-205-8071610020580180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-205-80) 2018-12-130000-00-00NoNoCurrent