divalproex sodium

Product NDC
0615-8587
11-digit product format
006158587
Labeler code
0615
Product ID
0615-8587_3898a9c6-b4ac-4240-94f1-3c76a3df6770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA078853
Marketing category
ANDA
Marketing start
2024-06-26
Substance
DIVALPROEX SODIUM
Active strength
250 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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099625, 1099678, 1099870

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
0615-8587-39divalproex sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNf936b9d0-a58f-4fa5-8db9-752dabb837a62
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNf936b9d0-a58f-4fa5-8db9-752dabb837a62
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNf936b9d0-a58f-4fa5-8db9-752dabb837a62
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDf936b9d0-a58f-4fa5-8db9-752dabb837a62
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDf936b9d0-a58f-4fa5-8db9-752dabb837a62
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDf936b9d0-a58f-4fa5-8db9-752dabb837a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8587-390061585873930 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8587-39) 2025-08-15NoNoCurrent