QELBREE

These highlights do not include all the information needed to use QELBREE safely and effectively. See full prescribing information for QELBREE . QELBREE (viloxazine extended-release capsules), for oral use Initial U.S. Approval: 2021

Approved

Approval ID

aedf408d-0f84-418d-9416-7c39ddb0d29a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers

FDA

Supernus Pharmaceuticals, Inc

DUNS: 363066452

Products 3

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

viloxazine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-133

Application NumberNDA211964

Product Classification

Marketing Category

C73594

Generic Name

viloxazine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (24)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

VILOXAZINE HYDROCHLORIDEActive

Quantity: 200 mg in 1 1

Code: OQW30I1332

Classification: ACTIM

viloxazine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-132

Application NumberNDA211964

Product Classification

Marketing Category

C73594

Generic Name

viloxazine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (24)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

VILOXAZINE HYDROCHLORIDEActive

Quantity: 150 mg in 1 1

Code: OQW30I1332

Classification: ACTIM

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

viloxazine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code17772-131

Application NumberNDA211964

Product Classification

Marketing Category

C73594

Generic Name

viloxazine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 20, 2023

FDA Product Classification

INGREDIENTS (24)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7U

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

VILOXAZINE HYDROCHLORIDEActive

Quantity: 100 mg in 1 1

Code: OQW30I1332

Classification: ACTIM

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

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QELBREE

Products 3

viloxazine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

viloxazine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

viloxazine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

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