FDA.reportPublic FDA data

0.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe

RxCUI
1433768
RxNorm name
0.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe
Display name
0.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe
Full name
0.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe
Term type
SCD
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#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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-b72866959644tbo-filgrastim 300 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML tbo-filgrastim 0.6 MG/ML Prefilled Syringe [SCD] · tbo-filgrastim 300 MCG per 0.5 ML Prefilled Syringe [SY]326These 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