XPOVIO

These highlights do not include all the information needed to use XPOVIO safely and effectively. See full prescribing information for XPOVIO. XPOVIO (selinexor) tablets, for oral useInitial U.S. Approval: 2019

Approved

Approval ID

f6dd2682-75a6-4863-90a8-a3197f6f78a8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2022

Manufacturers

FDA

Karyopharm Therapeutics Inc.

DUNS: 061317680

Products 4

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

selinexor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72237-101

Application NumberNDA212306

Product Classification

Marketing Category

C73594

Generic Name

selinexor

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (16)

selinexorActive

Quantity: 20 mg in 1 1

Code: 31TZ62FO8F

Classification: ACTIB

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

Microcrystalline Cellulose 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

Microcrystalline Cellulose 102Inactive

Code: PNR0YF693Y

Classification: IACT

Povidone K30Inactive

Code: U725QWY32X

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

selinexor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72237-102

Application NumberNDA212306

Product Classification

Marketing Category

C73594

Generic Name

selinexor

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (16)

selinexorActive

Quantity: 40 mg in 1 1

Code: 31TZ62FO8F

Classification: ACTIB

Microcrystalline Cellulose 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

Microcrystalline Cellulose 102Inactive

Code: PNR0YF693Y

Classification: IACT

Povidone K30Inactive

Code: U725QWY32X

Classification: IACT

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

selinexor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72237-104

Application NumberNDA212306

Product Classification

Marketing Category

C73594

Generic Name

selinexor

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (16)

Microcrystalline Cellulose 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

selinexorActive

Quantity: 60 mg in 1 1

Code: 31TZ62FO8F

Classification: ACTIB

Microcrystalline Cellulose 102Inactive

Code: PNR0YF693Y

Classification: IACT

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

Povidone K30Inactive

Code: U725QWY32X

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

selinexor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72237-103

Application NumberNDA212306

Product Classification

Marketing Category

C73594

Generic Name

selinexor

Product Specifications

Route of AdministrationORAL

Effective DateJuly 25, 2022

FDA Product Classification

INGREDIENTS (16)

selinexorActive

Quantity: 50 mg in 1 1

Code: 31TZ62FO8F

Classification: ACTIB

Microcrystalline Cellulose 102Inactive

Code: PNR0YF693Y

Classification: IACT

Microcrystalline Cellulose 101Inactive

Code: 7T9FYH5QMK

Classification: IACT

Povidone K30Inactive

Code: U725QWY32X

Classification: IACT

Croscarmellose SodiumInactive

Code: M28OL1HH48

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

Magnesium StearateInactive

Code: 70097M6I30

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

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XPOVIO

Products 4

selinexor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

selinexor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

selinexor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

selinexor

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

MedPath

Product

Company

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