Injectafer
These highlights do not include all the information needed to use Injectafer safely and effectively. See full prescribing information for Injectafer. INJECTAFER (ferric carboxymaltose injection), f or intravenous use Initial U.S. Approval: 2013
Approved
Approval ID
517b4a19-45b3-4286-9f6a-ced4e10447de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2023
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.
Ferric Carboxymaltose Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0602
Application NumberNDA203565
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric Carboxymaltose Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (1)
FERRIC CARBOXYMALTOSEActive
Quantity: 50 mg in 1 mL
Code: 6897GXD6OE
Classification: ACTIM
Ferric Carboxymaltose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0620
Application NumberNDA203565
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric Carboxymaltose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (1)
FERRIC CARBOXYMALTOSEActive
Quantity: 50 mg in 1 mL
Code: 6897GXD6OE
Classification: ACTIM
Ferric Carboxymaltose Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0650
Application NumberNDA203565
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ferric Carboxymaltose Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (1)
FERRIC CARBOXYMALTOSEActive
Quantity: 50 mg in 1 mL
Code: 6897GXD6OE
Classification: ACTIM