Trokendi XR

These highlights do not include all the information needed to use TROKENDI XR safely and effectively. See full prescribing information for TROKENDI XR. TROKENDI XR (topiramate) extended-release capsules, for oral use Initial U.S. Approval: 1996

Approved

Approval ID

2dc7957e-a3e5-46bb-aa66-f3250f872f5e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers

FDA

Supernus Pharmaceuticals

DUNS: 363066452

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

topiramate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-102

Application NumberNDA201635

Product Classification

Marketing Category

C73594

Generic Name

topiramate

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (21)

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

TOPIRAMATEActive

Quantity: 50 mg in 1 1

Code: 0H73WJJ391

Classification: ACTIB

DOCUSATE SODIUM/SODIUM BENZOATEInactive

Code: 656HXR6YXN

Classification: IACT

topiramate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-101

Application NumberNDA201635

Product Classification

Marketing Category

C73594

Generic Name

topiramate

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (20)

DOCUSATE SODIUM/SODIUM BENZOATEInactive

Code: 656HXR6YXN

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

RIBOFLAVINInactive

Code: TLM2976OFR

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TOPIRAMATEActive

Quantity: 25 mg in 1 1

Code: 0H73WJJ391

Classification: ACTIB

topiramate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-103

Application NumberNDA201635

Product Classification

Marketing Category

C73594

Generic Name

topiramate

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (20)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TOPIRAMATEActive

Quantity: 100 mg in 1 1

Code: 0H73WJJ391

Classification: ACTIB

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

DOCUSATE SODIUM/SODIUM BENZOATEInactive

Code: 656HXR6YXN

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

topiramate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-104

Application NumberNDA201635

Product Classification

Marketing Category

C73594

Generic Name

topiramate

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (20)

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

DOCUSATE SODIUM/SODIUM BENZOATEInactive

Code: 656HXR6YXN

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TOPIRAMATEActive

Quantity: 200 mg in 1 1

Code: 0H73WJJ391

Classification: ACTIB

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Trokendi XR

Products 4

topiramate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

topiramate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

topiramate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

topiramate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

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