Visudyne
These highlights do not include all the information needed to use VISUDYNE safely and effectively. See full prescribing information for VISUDYNE. VISUDYNE (verteporfin for injection), for intravenous useInitial U.S. Approval: 2000
Approved
Approval ID
952f4c80-50b1-4308-9ee6-311ffefb13df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2021
Manufacturers
FDA
Bausch Health US LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
verteporfin for injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-5600
Application NumberNDA021119
Product Classification
M
Marketing Category
C73594
G
Generic Name
verteporfin for injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 21, 2021
FDA Product Classification
INGREDIENTS (4)
VERTEPORFINActive
Quantity: 15 mg in 1 1
Code: 0X9PA28K43
Classification: ACTIB
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT