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 for oral administration. Divalproex Sodium Extended-release TabletsInitial U.S. Approval: 2000
Approved
Approval ID
a24e8e53-07b3-49be-87e4-124f7d3aeac1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-122
Application NumberANDA077567
Product Classification
M
Marketing Category
C73584
G
Generic Name
divalproex sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2008
FDA Product Classification
INGREDIENTS (12)
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT