Divalproex Sodium

Product NDC
67046-1571
11-digit product format
670461571
Labeler code
67046
Product ID
67046-1571_38f4e70f-be4f-ae1d-e063-6394a90ae3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078597
Marketing category
ANDA
Marketing start
2025-07-02
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
67046-1571-36704615710330 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1571-3) 2025-07-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Divalproex SodiumCoupler LLC2025-07-02HUMAN PRESCRIPTION DRUG LABEL1