FDA.reportPublic FDA data

0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend]

RxCUI
2613769
RxNorm name
0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend]
Display name
0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend]
Full name
0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761173Stimufendpegfilgrastim-fpgk351(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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STIMUFENDPEGFLILGRASTIM-FPGKNORTHSTAR RX LLC1e36ee55-7f13-41db-9d49-2f7a92f3b7502025-11-30Warnings, Adverse reactionsExact identifier
rxcui: 2613769
STIMUFENDPEGFLILGRASTIM-FPGKFresenius Kabi USA, LLCb44bcb82-7e60-4dab-a658-115bdf5c053c2023-10-24Warnings, Adverse reactionsExact identifier
rxcui: 2613769

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b44bcb82-7e60-4dab-a658-115bdf5c053cStimufend 6 MG in 0.6 ML Prefilled Syringe [PSN] · 0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend] [SBD] · 0.6 ML Stimufend 10 MG/ML Prefilled Syringe [SY] · Stimufend 6 MG per 0.6 ML Prefilled Syringe [SY]44These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND ® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) 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 meaningful di20231024
1e36ee55-7f13-41db-9d49-2f7a92f3b750Stimufend 6 MG in 0.6 ML Prefilled Syringe [PSN] · 0.6 ML pegfilgrastim-fpgk 10 MG/ML Prefilled Syringe [Stimufend] [SBD] · 0.6 ML Stimufend 10 MG/ML Prefilled Syringe [SY] · Stimufend 6 MG per 0.6 ML Prefilled Syringe [SY]41These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND ® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) 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 meaningful di20251130