Fetroja
These highlights do not include all the information needed to use FETROJA safely and effectively. See full prescribing information for FETROJA. FETROJA (cefiderocol) for injection, for intravenous use Initial U.S. Approval: 2019
Approved
Approval ID
75c0c785-38e0-4049-a6fb-b77581f5b35c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2021
Manufacturers
FDA
Shionogi Inc.
DUNS: 098241610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefiderocol sulfate tosylate
PRODUCT DETAILS
NDC Product Code59630-266
Application NumberNDA209445
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateNovember 19, 2021
Generic NameCefiderocol sulfate tosylate
INGREDIENTS (5)
Cefiderocol sulfate tosylateActive
Quantity: 1 g in 10 mL
Code: TTP8LBP45D
Classification: ACTIM
Sodium chlorideInactive
Quantity: 216 mg in 10 mL
Code: 451W47IQ8X
Classification: IACT
SucroseInactive
Quantity: 900 mg in 10 mL
Code: C151H8M554
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT