EXXUA

Basic Information

Product Name

EXXUA

FDA Product Code

83504-153

Regulatory Information

NDC Product Code

83504-153

Application Number

NDA021164

Marketing Category

C73594

Effective Date

February 12, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use EXXUA safely and effectively. See full prescribing information for EXXUA. EXXUA (gepirone) extended-release tablets, for oral use Initial U.S. Approval: 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

GEPIRONE HYDROCHLORIDE

Quantity: 72.6 mg in 1 1

Code: 80C9L8EP6V

Class Code: ACTIM

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

GEPIRONE

Code: JW5Y7B8Z18

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

HYPROMELLOSE, UNSPECIFIED

FERRIC OXIDE RED

MAGNESIUM STEARATE

FERRIC OXIDE YELLOW

MICROCRYSTALLINE CELLULOSE

Active Moieties

GEPIRONE