VISTOGARD
These highlights do not include all the information needed to use VISTOGARD safely and effectively. See full prescribing information for VISTOGARD. VISTOGARD (uridine triacetate) oral granulesInitial U.S. Approval: 2015
Approved
Approval ID
5a0ba417-8a4a-4d7f-b85a-1839ee8bd3f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2018
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69468-151
Application NumberNDA208159
Product Classification
M
Marketing Category
C73594
G
Generic Name
uridine triacetate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2017
FDA Product Classification
INGREDIENTS (5)
uridine triacetateActive
Quantity: 951 mg in 1 g
Code: 2WP61F175M
Classification: ACTIB
ORANGE JUICEInactive
Code: 5A9KE2L9L3
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT