FDA.reportPublic FDA data

1.6 ML tbo-filgrastim 0.3 MG/ML Injection [Granix]

RxCUI
2101465
RxNorm name
1.6 ML tbo-filgrastim 0.3 MG/ML Injection [Granix]
Display name
1.6 ML tbo-filgrastim 0.3 MG/ML Injection [Granix]
Full name
1.6 ML tbo-filgrastim 0.3 MG/ML Injection [Granix]
Term type
SBD
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#

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

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 1.6 ML Injection [PSN] · 1.6 ML tbo-filgrastim 0.3 MG/ML Injection [Granix] [SBD] · Granix 0.3 MG/ML per 1.6 ML Injection [SY] · Granix 480 MCG per 1.6 ML Injection [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