DIVALPROEX SODIUM

Divalproex Sodium Delayed-Release Tablets, USP Rx only

Approved

Approval ID

cdce6a8f-02fc-448c-9a81-3d904e49ef97

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2011

Manufacturers

FDA

WOCKHARDT LIMITED

DUNS: 650069115

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 Code55648-975

Application NumberANDA077296

Product Classification

Marketing Category

C73584

Generic Name

DIVALPROEX SODIUM

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 1, 2011

FDA Product Classification

INGREDIENTS (18)

DIVALPROEX SODIUMActive

Quantity: 500 mg in 1 1

Code: 644VL95AO6

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

GLYCERYL BEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DIVALPROEX SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55648-973

Application NumberANDA077296

Product Classification

Marketing Category

C73584

Generic Name

DIVALPROEX SODIUM

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 1, 2011

FDA Product Classification

INGREDIENTS (18)

DIVALPROEX SODIUMActive

Quantity: 125 mg in 1 1

Code: 644VL95AO6

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

GLYCERYL BEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DIVALPROEX SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code55648-974

Application NumberANDA077296

Product Classification

Marketing Category

C73584

Generic Name

DIVALPROEX SODIUM

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 1, 2011

FDA Product Classification

INGREDIENTS (18)

DIVALPROEX SODIUMActive

Quantity: 250 mg in 1 1

Code: 644VL95AO6

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

GLYCERYL BEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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DIVALPROEX SODIUM

Products 3

DIVALPROEX SODIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

DIVALPROEX SODIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

DIVALPROEX SODIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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