Divalproex sodium

Product NDC
0615-8376
11-digit product format
006158376
Labeler code
0615
Product ID
0615-8376_efe6fc7b-e709-4f0d-ba7f-ffb7a87ad155
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA209286
Marketing category
ANDA
Marketing start
2020-09-18
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8376-390061583763930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8376-39) 2021-01-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Divalproex sodiumNCS HealthCare of KY, LLC dba Vangard Labs2024-09-13HUMAN PRESCRIPTION DRUG LABEL6