Sodium Ferric Gluconate Complex in Sucrose
These highlights do not include all the information needed to use sodium ferric gluconate complex in sucrose injection safely and effectively. See full prescribing information for sodium ferric gluconate complex in sucrose injection. Sodium ferric gluconate complex in sucrose injection, for intravenous use Initial U.S. Approval: 1999
Approved
Approval ID
218d1b8d-b24f-4f77-b588-97c7dd1c2eec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Ferric Gluconate Complex in Sucrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9570
Application NumberANDA078215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Ferric Gluconate Complex in Sucrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (4)
SODIUM FERRIC GLUCONATE COMPLEXActive
Quantity: 12.5 mg in 1 mL
Code: CC9149U2QX
Classification: ACTIM
SUCROSEInactive
Quantity: 195 mg in 1 mL
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT