FDA.reportPublic FDA data

Fetroja

Product NDC
59630-266
11-digit product format
596300266
Labeler code
59630
Product ID
59630-266_64c35e73-1daa-4a82-a3c2-a737dec6eeae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefiderocol sulfate tosylate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Shionogi Inc.
Application
NDA209445
Marketing category
NDA
Marketing start
2020-01-31
Substance
CEFIDEROCOL SULFATE TOSYLATE
Active strength
1 g/10mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fetroja
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFIDEROCOL SULFATE TOSYLATE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTTP8LBP45D
Rxcui2265706, 2265711

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bbc5324-1064-4ef2-953c-4c9fb2e47aaaProduct name120200429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59630-266-01Fetroja10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION1011
59630-266-10Fetroja10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59630-266-01EA - Each59630-266b16f68cf-47eb-44f5-84ad-9314e465cf8f12020-03-10
59630-266-10EA - Each59630-266e7235c49-783f-411e-92d9-9cf933717ed012020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59630-266FETROJA (CEFIDEROCOL SULFATE TOSYLATE) INJECTION, POWDER, FOR SOLUTION [SHIONOGI INC.]8Current NDC, Legacy NDC, 2 package rows20240928_75c0c785-38e0-4049-a6fb-b77581f5b35c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2265706cefiderocol 1 GM InjectionPSN75c0c785-38e0-4049-a6fb-b77581f5b35c11
2265711FETROJA 1 GM InjectionPSN75c0c785-38e0-4049-a6fb-b77581f5b35c11
2265711cefiderocol 1000 MG Injection [Fetroja]SBD75c0c785-38e0-4049-a6fb-b77581f5b35c11
2265706cefiderocol 1000 MG InjectionSCD75c0c785-38e0-4049-a6fb-b77581f5b35c11
2265706cefiderocol (as cefiderocol sulfate tosylate) 1 GM InjectionSY75c0c785-38e0-4049-a6fb-b77581f5b35c11
2265711Fetroja 1 GM InjectionSY75c0c785-38e0-4049-a6fb-b77581f5b35c11
2265711Fetroja 1000 MG InjectionSY75c0c785-38e0-4049-a6fb-b77581f5b35c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59630-266-015963002660110 mL in 1 VIAL, SINGLE-USE10 mlHistorical
59630-266-105963002661010 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01) 2020-01-310000-00-00NoNoCurrent