Depakote
These highlights do not include all the information needed to use Depakote ER safely and effectively. See full prescribing information for Depakote ER.Depakote ER (divalproex sodium) Tablet, Extended Release for Oral useInitial U.S. Approval: 2000
Approved
Approval ID
ded64147-7a43-4055-accc-2c011828079d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-5525
Application NumberNDA021168
Product Classification
M
Marketing Category
C73594
G
Generic Name
divalproex sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2011
FDA Product Classification
INGREDIENTS (7)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 250 mg in 1 1
Code: 644VL95AO6
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
divalproex sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4959
Application NumberNDA021168
Product Classification
M
Marketing Category
C73594
G
Generic Name
divalproex sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2011
FDA Product Classification
INGREDIENTS (7)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT