Venofer
These highlights do not include all the information needed to use VENOFER safely and effectively. See full prescribing information for VENOFER.Venofer (iron sucrose) injection, for intravenous useInitial U.S. Approval: 2000
Approved
Approval ID
626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2022
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iron sucrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-2340
Application NumberNDA021135
Product Classification
M
Marketing Category
C73594
G
Generic Name
iron sucrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (2)
IRON SUCROSEActive
Quantity: 20 mg in 1 mL
Code: FZ7NYF5N8L
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
iron sucrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-2325
Application NumberNDA021135
Product Classification
M
Marketing Category
C73594
G
Generic Name
iron sucrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
IRON SUCROSEActive
Quantity: 20 mg in 1 mL
Code: FZ7NYF5N8L
Classification: ACTIM
iron sucrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-2310
Application NumberNDA021135
Product Classification
M
Marketing Category
C73594
G
Generic Name
iron sucrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
IRON SUCROSEActive
Quantity: 20 mg in 1 mL
Code: FZ7NYF5N8L
Classification: ACTIM