FDA.reportPublic FDA data

0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]

RxCUI
2703026
RxNorm name
0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]
Display name
0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]
Full name
0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:18

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761411Niktimvoaxatilimab-csfr351(a)Disc2026-07-01

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
NIKTIMVOAXATILIMAB-CSFRIncyte Corporationbb6dba23-e7a6-4765-a1e6-b9e277ce03812026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2703026

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
bb6dba23-e7a6-4765-a1e6-b9e277ce0381Niktimvo 9 MG in 0.18 ML Injection [PSN] · 0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo] [SBD] · 0.18 ML Niktimvo 50 MG/ML Injection [SY] · Niktimvo 9 MG per 0.18 ML Injection [SY]45These highlights do not include all the information needed to use NIKTIMVO safely and effectively. See full prescribing information for NIKTIMVO. NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use Initial U.S. Approval: 202420250116