Divalproex Sodium
Divalproex Sodium Delayed-Release Tablets USP 125 mg, 250 mg and 500 mg
Approved
Approval ID
9b3db659-f64c-4c48-946a-6b4f1d800eba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 3
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 Code21695-819
Application NumberANDA078790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Divalproex Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (16)
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Divalproex Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-818
Application NumberANDA078790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Divalproex Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 250 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Divalproex Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-817
Application NumberANDA078790
Product Classification
M
Marketing Category
C73584
G
Generic Name
Divalproex Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 125 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT