FDA.reportPublic FDA data

0.8 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym]

RxCUI
2057216
RxNorm name
0.8 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym]
Display name
0.8 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym]
Full name
0.8 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761080Nivestymfilgrastim-aafi351(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
NivestymFILGRASTIM-AAFIPfizer Laboratories Div Pfizer Incd23ab39c-b6ec-41cf-a529-9dd2852c9d9a2025-08-12Warnings, Adverse reactionsExact identifier
rxcui: 2057216

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
d23ab39c-b6ec-41cf-a529-9dd2852c9d9aNivestym 480 MCG in 0.8 ML Prefilled Syringe [PSN] · 0.8 ML filgrastim-aafi 0.6 MG/ML Prefilled Syringe [Nivestym] [SBD] · Nivestym 0.6 MG/ML per 0.8 ML Prefilled Syringe [SY] · Nivestym 480 MCG per 0.8 ML Prefilled Syringe [SY]418These highlights do not include all the information needed to use NIVESTYM safely and effectively. See full prescribing information for NIVESTYM. NIVESTYM™ (filgrastim-aafi) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2018 NIVESTYM (filgrastim-aafi) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningfu20250812