FDA.reportPublic FDA data

Granix 480 MCG in 0.8 ML Prefilled Syringe

RxCUI
1442683
RxNorm name
Granix 480 MCG in 0.8 ML Prefilled Syringe
Display name
Granix 480 MCG in 0.8 ML Prefilled Syringe
Full name
Granix 480 MCG in 0.8 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125294Granixtbo-filgrastim351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
df918ec2-0907-443f-a52a-b72866959644Granix 480 MCG in 0.8 ML Prefilled Syringe [PSN] · 0.8 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe [Granix] [SBD] · 0.8 ML Granix 0.6 MG/ML Prefilled Syringe [SY] · Granix 480 MCG per 0.8 ML Prefilled Syringe [SY]426These highlights do not include all the information needed to use GRANIX safely and effectively. See full prescribing information for GRANIX. GRANIX ® (tbo-filgrastim) injection, for subcutaneous use Initial U.S. Approval: 201220231130