XURIDEN
These highlights do not include all the information needed to use XURIDEN safely and effectively. See full prescribing information for XURIDEN. XURIDEN® (uridine triacetate) oral granulesInitial U.S. Approval: 2015
Approved
Approval ID
40606ca9-4f14-45b7-8632-fc2d17d11a2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2022
Manufacturers
FDA
Wellstat Therapeutics Corporation
DUNS: 785233024
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
uridine triacetate
PRODUCT DETAILS
NDC Product Code69468-152
Application NumberNDA208169
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 16, 2019
Generic Nameuridine triacetate
INGREDIENTS (5)
uridine triacetateActive
Quantity: 951 mg in 1 g
Code: 2WP61F175M
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ORANGE JUICEInactive
Code: 5A9KE2L9L3
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT