FDA.reportPublic FDA data

ceftaroline fosamil 400 MG Injection

RxCUI
1040008
RxNorm name
ceftaroline fosamil 400 MG Injection
Display name
Ceftaroline fosamil (Injectable)
Full name
ceftaroline fosamil 400 MG Injection
Term type
SCD
Status
Active
Strength
400 mg
Dose form
Injection
Route
Injectable
Updated
2026-10-06 01:43:45

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
ceftaroline fosamil400 MG / 1 EACHceftaroline fosamilceftaroline fosamil

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
ceftaroline fosamil1040004

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRceftaroline fosamil 400 MG Injection1NAMES
RxNorm Nameceftaroline fosamil 400 MG Injection1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10400081CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
60505-4946-160505-4946Ceftaroline Fosamil Ceftaroline FosamilApotex Corp.ANDA208075
60505-6124-160505-6124Ceftaroline Fosamil Ceftaroline FosamilApotex Corp.ANDA208075

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20807560505-4946Ceftaroline Fosamil Ceftaroline FosamilANDAApotex Corp.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
60505494600rxnav_ndcsyes
60505494601rxnav_ndcsyes
60505612400rxnav_ndcsyes
60505612401rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceftaroline FosamilCEFTAROLINE FOSAMILApotex Corp.3cee3c08-ed60-06c5-ac49-103b7ad2ef5f2026-05-29Warnings, Adverse reactionsExact identifier
ndc (package): 60505-6124-1
ndc (product): 60505-6124
ndc11 (package): 60505612401
ndc11 (package): 60505612400
rxcui: 1040008
TeflaroCEFTAROLINE FOSAMILAllergan, Inc.3ecde48b-75a2-4beb-9999-369f3f61bb8a2024-11-20Warnings, Adverse reactionsExact identifier
rxcui: 1040008

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3ecde48b-75a2-4beb-9999-369f3f61bb8aceftaroline fosamil 400 MG Injection [PSN] · ceftaroline fosamil 400 MG Injection [SCD]243These highlights do not include all the information needed to use T EFLARO safely and effectively. See full prescribing information for TE FLARO . TE FLARO ® (ceftaroline fosamil) for injection , for intravenous use Initial U.S. Approval: 201020241120
3cee3c08-ed60-06c5-ac49-103b7ad2ef5fceftaroline fosamil 400 MG Injection [PSN] · ceftaroline fosamil 400 MG Injection [SCD]26These highlights do not include all the information needed to use CEFTAROLINE FOSAMIL FOR INJECTION safely and effectively. See full prescribing information for CEFTAROLINE FOSAMIL FOR INJECTION. CEFTAROLINE FOSAMIL for injection, for intravenous use Initial U.S. Approval: 201020260213

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
9ec2cc88-fbec-a5aa-df85-ecff7350d813These highlights do not include all the information needed to use CEFTAROLINE FOSAMIL FOR INJECTION safely and effectively. See full prescribing information for CEFTAROLINE FOSAMIL FOR INJECTION. CEFTAROLINE FOSAMIL for injection, for intravenous use Initial U.S. Approval: 2010Apotex Corp.20261001
9ec2cc88-fbec-a5aa-df85-ecff7350d813These highlights do not include all the information needed to use CEFTAROLINE FOSAMIL FOR INJECTION safely and effectively. See full prescribing information for CEFTAROLINE FOSAMIL FOR INJECTION. CEFTAROLINE FOSAMIL for injection, for intravenous use Initial U.S. Approval: 2010Apotex Corp.20260821
3cee3c08-ed60-06c5-ac49-103b7ad2ef5fThese highlights do not include all the information needed to use CEFTAROLINE FOSAMIL FOR INJECTION safely and effectively. See full prescribing information for CEFTAROLINE FOSAMIL FOR INJECTION. CEFTAROLINE FOSAMIL for injection, for intravenous use Initial U.S. Approval: 2010Apotex Corp.20260529
3cee3c08-ed60-06c5-ac49-103b7ad2ef5fThese highlights do not include all the information needed to use CEFTAROLINE FOSAMIL FOR INJECTION safely and effectively. See full prescribing information for CEFTAROLINE FOSAMIL FOR INJECTION. CEFTAROLINE FOSAMIL for injection, for intravenous use Initial U.S. Approval: 2010Apotex Corp.20260213

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCJ01DIOther cephalosporins and penemsATC1-4ceftaroline fosamil
MEDRTD000097583CeftarolineCHEMhas_ingredientceftaroline fosamil
MEDRTD004342Drug HypersensitivityDISEASEci_withceftaroline fosamil
MEDRTD004927Escherichia coli InfectionsDISEASEmay_treatceftaroline fosamil
MEDRTD007710Klebsiella InfectionsDISEASEmay_treatceftaroline fosamil
MEDRTD011014PneumoniaDISEASEmay_treatceftaroline fosamil
MEDRTD012874Skin Diseases, InfectiousDISEASEmay_treatceftaroline fosamil
MEDRTD013203Staphylococcal InfectionsDISEASEmay_treatceftaroline fosamil
MEDRTD013290Streptococcal InfectionsDISEASEmay_treatceftaroline fosamil
MEDRTN0000000133Enzyme InhibitorsMOAhas_moaceftaroline fosamil
MEDRTN0000008479Decreased Cell Wall Synthesis & RepairPEhas_peceftaroline fosamil

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH400 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA208075
CODESVUID4030285
NAMESPrescribable Synonymceftaroline fosamil 400 MG Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File