Epclusa

These highlights do not include all the information needed to use EPCLUSA safely and effectively. See full prescribing information for EPCLUSA. EPCLUSA (sofosbuvir and velpatasvir) tablets, for oral use EPCLUSA (sofosbuvir and velpatasvir) oral pellets Initial U.S. Approval: 2016

Approved

Approval ID

7f30631a-ee3b-4cfe-866b-964df3f0a44f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 2, 2022

Manufacturers

FDA

Gilead Sciences, Inc.

DUNS: 185049848

Products 4

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

Velpatasvir and Sofosbuvir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code61958-2201

Application NumberNDA208341

Product Classification

Marketing Category

C73594

Generic Name

Velpatasvir and Sofosbuvir

Product Specifications

Route of AdministrationORAL

Effective DateApril 30, 2022

FDA Product Classification

INGREDIENTS (13)

VELPATASVIRActive

Quantity: 100 mg in 1 1

Code: KCU0C7RS7Z

Classification: ACTIB

SOFOSBUVIRActive

Quantity: 400 mg in 1 1

Code: WJ6CA3ZU8B

Classification: ACTIB

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Velpatasvir and Sofosbuvir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code61958-2204

Application NumberNDA214187

Product Classification

Marketing Category

C73594

Generic Name

Velpatasvir and Sofosbuvir

Product Specifications

Route of AdministrationORAL

Effective DateApril 30, 2022

FDA Product Classification

INGREDIENTS (17)

VELPATASVIRActive

Quantity: 50 mg in 1 1

Code: KCU0C7RS7Z

Classification: ACTIB

SOFOSBUVIRActive

Quantity: 200 mg in 1 1

Code: WJ6CA3ZU8B

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive

Code: 905HNO1SIH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Velpatasvir and Sofosbuvir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code61958-2205

Application NumberNDA214187

Product Classification

Marketing Category

C73594

Generic Name

Velpatasvir and Sofosbuvir

Product Specifications

Route of AdministrationORAL

Effective DateApril 30, 2022

FDA Product Classification

INGREDIENTS (17)

VELPATASVIRActive

Quantity: 37.5 mg in 1 1

Code: KCU0C7RS7Z

Classification: ACTIB

SOFOSBUVIRActive

Quantity: 150 mg in 1 1

Code: WJ6CA3ZU8B

Classification: ACTIB

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TARTARIC ACIDInactive

Code: W4888I119H

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive

Code: 905HNO1SIH

Classification: IACT

Velpatasvir and Sofosbuvir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code61958-2203

Application NumberNDA208341

Product Classification

Marketing Category

C73594

Generic Name

Velpatasvir and Sofosbuvir

Product Specifications

Route of AdministrationORAL

Effective DateApril 30, 2022

FDA Product Classification

INGREDIENTS (13)

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

VELPATASVIRActive

Quantity: 50 mg in 1 1

Code: KCU0C7RS7Z

Classification: ACTIB

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SOFOSBUVIRActive

Quantity: 200 mg in 1 1

Code: WJ6CA3ZU8B

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Epclusa

Products 4

Velpatasvir and Sofosbuvir

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Velpatasvir and Sofosbuvir

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Velpatasvir and Sofosbuvir

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Velpatasvir and Sofosbuvir

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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