FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
68788-4100
11-digit product format
687884100
Labeler code
68788
Product ID
68788-4100_dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090070
Marketing category
ANDA
Marketing start
2026-04-20
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4100-3Divalproex Sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE301
68788-4100-6Divalproex Sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE601
68788-4100-9Divalproex Sodium90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNdc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDdc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYdc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4100-36878841000330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4100-3) 2026-04-20NoNoCurrent
68788-4100-66878841000660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4100-6) 2026-04-20NoNoCurrent
68788-4100-96878841000990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4100-9) 2026-04-20NoNoCurrent