FDA.reportPublic FDA data

0.5 ML Zarxio 0.6 MG/ML Prefilled Syringe

RxCUI
1605071
RxNorm name
0.5 ML Zarxio 0.6 MG/ML Prefilled Syringe
Display name
0.5 ML Zarxio 0.6 MG/ML Prefilled Syringe
Full name
0.5 ML Zarxio 0.6 MG/ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125553Zarxiofilgrastim-sndz351(k) BiosimilarRx2026-08-01

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
ZARXIOFILGRASTIM-SNDZSandoz Inc.c0d1c22b-566b-4776-bdbf-00f96dad0cae2025-08-29Warnings, Adverse reactionsExact identifier
rxcui: 1605071

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
c0d1c22b-566b-4776-bdbf-00f96dad0caeZarxio 300 MCG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML filgrastim-sndz 0.6 MG/ML Prefilled Syringe [Zarxio] [SBD] · 0.5 ML Zarxio 0.6 MG/ML Prefilled Syringe [SY] · Zarxio 300 MCG per 0.5 ML Prefilled Syringe [SY]413These highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO ® (filgrastim-sndz) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2015 ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim).20250829