Divalproex Sodium

These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1983

Approved

Approval ID

b95494e2-ee7a-7415-e053-2995a90ae852

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2023

Manufacturers

FDA

BluePoint Laboratories

DUNS: 985523874

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 Code68001-473

Application NumberANDA079163

Product Classification

Marketing Category

C73584

Generic Name

Divalproex Sodium

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2023

FDA Product Classification

INGREDIENTS (25)

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

MICROCRYSTALLINE CELLULOSE 112Inactive

Code: X7XJ6RM9Q2

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

VANILLINInactive

Code: CHI530446X

Classification: IACT

DIVALPROEX SODIUMActive

Quantity: 250 mg in 1 1

Code: 644VL95AO6

Classification: ACTIM

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Divalproex Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68001-472

Application NumberANDA079163

Product Classification

Marketing Category

C73584

Generic Name

Divalproex Sodium

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2023

FDA Product Classification

INGREDIENTS (24)

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

MICROCRYSTALLINE CELLULOSE 112Inactive

Code: X7XJ6RM9Q2

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DIVALPROEX SODIUMActive

Quantity: 125 mg in 1 1

Code: 644VL95AO6

Classification: ACTIM

VANILLINInactive

Code: CHI530446X

Classification: IACT

Divalproex Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code68001-474

Application NumberANDA079163

Product Classification

Marketing Category

C73584

Generic Name

Divalproex Sodium

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2023

FDA Product Classification

INGREDIENTS (23)

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

MICROCRYSTALLINE CELLULOSE 112Inactive

Code: X7XJ6RM9Q2

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QO

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

VANILLINInactive

Code: CHI530446X

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DIVALPROEX SODIUMActive

Quantity: 500 mg in 1 1

Code: 644VL95AO6

Classification: ACTIM

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Divalproex Sodium

Products 3

Divalproex Sodium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Divalproex Sodium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

Divalproex Sodium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

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