divalproex sodium

Product NDC
0615-8588
11-digit product format
006158588
Labeler code
0615
Product ID
0615-8588_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
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
644VL95AO6DIVALPROEX SODIUM76584-70-8DIVALPROEX SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8588-390061585883930 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8588-39) 2025-08-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
divalproex sodiumNCS HealthCare of KY, LLC dba Vangard Labs | Bionpharma Inc.2025-11-14HUMAN PRESCRIPTION DRUG LABEL2