Divalproex Sodium
These highlights do not include all the information needed to use divalproex sodium extended-release tablets safely and effectively. See full prescribing information for divalproex sodium extended-release tablets. Divalproex sodium extended-release tablets for oral administrationInitial U.S. Approval: 2000
Approved
Approval ID
26b65fec-9a5d-4b9b-9b87-c3d328c58cd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
divalproex sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6088
Application NumberANDA078445
Product Classification
M
Marketing Category
C73584
G
Generic Name
divalproex sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2011
FDA Product Classification
INGREDIENTS (10)
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT