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)Rx2026-08-01

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.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GRANIXTBO-FILGRASTIMCephalon, LLCdf918ec2-0907-443f-a52a-b728669596442023-11-30Warnings, Adverse reactionsExact identifier
rxcui: 2101465

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