fetroja

Generic: cefiderocol sulfate tosylate

Labeler: shionogi inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fetroja
Generic Name cefiderocol sulfate tosylate
Labeler shionogi inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cefiderocol sulfate tosylate 1 g/10mL

Manufacturer
Shionogi Inc.

Identifiers & Regulatory

Product NDC 59630-266
Product ID 59630-266_1a7c25f6-5220-4766-abf5-398538710a48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209445
Listing Expiration 2026-12-31
Marketing Start 2020-01-31

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59630266
Hyphenated Format 59630-266

Supplemental Identifiers

RxCUI
2265706 2265711
UNII
TTP8LBP45D

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fetroja (source: ndc)
Generic Name cefiderocol sulfate tosylate (source: ndc)
Application Number NDA209445 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)
source: ndc

Packages (1)

59630-266-10 10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)

Ingredients (1)

cefiderocol sulfate tosylate (1 g/10mL)

Linked Drug Pages (1)

Fetroja ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1a7c25f6-5220-4766-abf5-398538710a48", "openfda": {"unii": ["TTP8LBP45D"], "rxcui": ["2265706", "2265711"], "spl_set_id": ["75c0c785-38e0-4049-a6fb-b77581f5b35c"], "manufacturer_name": ["Shionogi Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10)  / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)", "package_ndc": "59630-266-10", "marketing_start_date": "20200131"}], "brand_name": "Fetroja", "product_id": "59630-266_1a7c25f6-5220-4766-abf5-398538710a48", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "59630-266", "generic_name": "Cefiderocol sulfate tosylate", "labeler_name": "Shionogi Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fetroja", "active_ingredients": [{"name": "CEFIDEROCOL SULFATE TOSYLATE", "strength": "1 g/10mL"}], "application_number": "NDA209445", "marketing_category": "NDA", "marketing_start_date": "20200131", "listing_expiration_date": "20261231"}